Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth

Jodie M Dodd; Leanne Jones; Vicki Flenady; Robert Cincotta; Caroline A Crowther

doi:10.1002/14651858.CD004947.pub3

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Figure 1

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Funnel plot of comparison: 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth, outcome: 1.3 Preterm birth less than 37 weeks.

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Analysis 1.1

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 1 Perinatal mortality.

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Analysis 1.2

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 2 Preterm birth less than 34 weeks.

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Analysis 1.3

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 3 Preterm birth less than 37 weeks.

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Analysis 1.4

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 4 Threatened preterm labour.

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Analysis 1.5

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 5 Spontaneous vaginal delivery.

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Analysis 1.6

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 6 Caesarean section.

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Analysis 1.7

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 7 Antenatal corticosteroids.

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Analysis 1.8

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 8 Antenatal tocolysis.

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Analysis 1.9

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 9 Infant birthweight less than 2500 g.

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Analysis 1.10

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 10 Respiratory distress syndrome.

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Analysis 1.11

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 11 Use of assisted ventilation.

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Analysis 1.12

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 12 Intraventricular haemorrhage ‐ all grades.

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Analysis 1.13

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 13 Intraventricular haemorrhage ‐ grade III or IV.

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Analysis 1.14

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 14 Periventricular leucomalacia.

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Analysis 1.15

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 15 Retinopathy of prematurity.

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Analysis 1.16

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 16 Necrotising enterocolitis.

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Analysis 1.17

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 17 Neonatal sepsis.

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Analysis 1.18

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 18 Patent ductus arteriosus.

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Analysis 1.19

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 19 Intrauterine fetal death.

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Analysis 1.20

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 20 Neonatal death.

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Analysis 1.21

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 21 Developmental delay.

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Analysis 1.22

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 22 Intellectual impairment.

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Analysis 1.23

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 23 Motor Impairment.

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Analysis 1.24

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 24 Visual Impairment.

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Analysis 1.25

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 25 Hearing Impairment.

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Analysis 1.26

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 26 Cerebral palsy.

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Analysis 1.27

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 27 Learning difficulties.

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Analysis 1.28

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 28 Height less than 5th centile.

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Analysis 1.29

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 29 Weight less than 5th centile.

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Analysis 1.30

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 30 Adverse drug reaction.

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Analysis 1.31

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 31 Pregnancy prolongation (weeks).

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Analysis 1.32

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 32 Apgar score < 7.

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Analysis 1.33

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 33 Admission to neonatal intensive care unit.

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Analysis 1.34

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 34 Neonatal length of hospital stay (days).

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Analysis 1.35

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 35 Infant weight at 6 months follow‐up (g).

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Analysis 1.36

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 36 Infant weight at 12 months follow‐up (g).

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Analysis 1.37

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 37 Infant weight at 24 months follow‐up (g).

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Analysis 1.38

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 38 Infant length at 6 months follow‐up (cm).

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Analysis 1.39

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 39 Infant length at 12 months follow‐up (cm).

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Analysis 1.40

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 40 Infant length at 24 months follow‐up (cm).

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Analysis 1.41

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 41 Infant head circumference at 6 months follow‐up (cm).

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Analysis 1.42

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 42 Infant head circumference at 12 months follow‐up (cm).

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Analysis 1.43

Comparison 1 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons), Outcome 43 Infant head circumference at 24 months follow‐up (cm).

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Analysis 2.1

Comparison 2 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons), Outcome 1 Preterm birth less than 37 weeks.

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Analysis 3.1

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 1 Perinatal death.

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Analysis 3.2

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 2 Preterm birth less than 37 weeks.

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Analysis 3.3

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 3 Threatened preterm labour.

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Analysis 3.4

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 4 Caesarean section.

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Analysis 3.5

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 5 Antenatal corticosteroids.

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Analysis 3.6

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 6 Need for tocolysis.

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Analysis 3.7

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 7 Respiratory distress syndrome.

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Analysis 3.8

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 8 Intraventricular haemorrhage ‐ all grades.

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Analysis 3.9

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 9 Intraventricular haemorrhage ‐ grade III or IV.

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Analysis 3.10

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 10 Necrotising enterocolitis.

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Analysis 3.11

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 11 Intrauterine fetal death.

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Analysis 3.12

Comparison 3 Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons), Outcome 12 Neonatal death.

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Analysis 4.1

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 1 Perinatal death.

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Analysis 4.2

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 2 Preterm birth less than 34 weeks.

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Analysis 4.3

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 3 Preterm labour.

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Analysis 4.4

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 4 Prelabour spontaneous rupture of membranes.

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Analysis 4.5

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 5 Side effects (any).

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Analysis 4.6

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 6 Side effects (injection site).

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Analysis 4.7

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 7 Side effects (urticaria).

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Analysis 4.8

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 8 Side effects (nausea).

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Analysis 4.9

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 9 Pregnancy prolongation (days).

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Analysis 4.10

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 10 Caesarean section.

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Analysis 4.11

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 11 Antenatal tocolysis.

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Analysis 4.12

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 12 Preterm birth less than 37 weeks.

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Analysis 4.13

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 13 Preterm birth less than 28 weeks.

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Analysis 4.14

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 14 Infant birthweight less than 2500 g.

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Analysis 4.15

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 15 Respiratory distress syndrome.

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Analysis 4.16

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 16 Apgar score < 7.

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Analysis 4.17

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 17 Need for assisted ventilation.

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Analysis 4.18

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 18 Intraventricular haemorrhage ‐ all grades.

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Analysis 4.19

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 19 Intraventricular haemorrhage ‐ grades III or IV.

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Analysis 4.20

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 20 Periventricular leucomalacia.

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Analysis 4.21

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 21 Retinopathy of prematurity.

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Analysis 4.22

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 22 Necrotising enterocolitis.

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Analysis 4.23

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 23 Neonatal sepsis.

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Analysis 4.24

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 24 Intrauterine fetal death.

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Analysis 4.25

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 25 Neonatal death.

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Analysis 4.26

Comparison 4 Progesterone versus placebo: ultrasound identified short cervix, singletons, Outcome 26 Admission to neonatal intensive care unit.

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Analysis 5.1

Comparison 5 Progesterone versus placebo: ultrasound identified short cervix, singletons by cumulative weekly dose (<500 mg v >=500 mg), Outcome 1 Periventricular leucomalacia.

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Analysis 5.2

Comparison 5 Progesterone versus placebo: ultrasound identified short cervix, singletons by cumulative weekly dose (<500 mg v >=500 mg), Outcome 2 Admission to neonatal intensive care unit.

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Analysis 6.1

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 1 Perinatal death.

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Analysis 6.2

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 2 Preterm birth less than 34 weeks.

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Analysis 6.3

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 3 Preterm PROM.

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Analysis 6.4

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 4 Adverse drug reaction.

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Analysis 6.5

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 5 Caesarean section.

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Analysis 6.6

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 6 Spontaneous birth.

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Analysis 6.7

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 7 Assisted birth.

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Analysis 6.8

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 8 Satisfaction with therapy.

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Analysis 6.9

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 9 Antenatal tocolysis.

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Analysis 6.10

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 10 Antenatal corticosteroids.

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Analysis 6.11

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 11 Preterm birth less than 37 weeks.

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Analysis 6.12

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 12 Preterm birth less than 28 weeks.

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Analysis 6.13

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 13 Infant birthweight less than 2500 g.

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Analysis 6.14

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 14 Apgar score < 7 at 5 minutes.

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Analysis 6.15

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 15 Respiratory distress syndrome.

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Analysis 6.16

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 16 Use of assisted ventilation.

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Analysis 6.17

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 17 Intraventricular haemorrhage ‐ grades III or IV.

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Analysis 6.18

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 18 Intraventricular haemorrhage ‐ all grades.

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Analysis 6.19

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 19 Periventricular leucomalacia.

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Analysis 6.20

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 20 Retinopathy of prematurity.

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Analysis 6.21

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 21 Chronic lung disease.

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Analysis 6.22

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 22 Necrotising enterocolitis.

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Analysis 6.23

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 23 Neonatal sepsis.

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Analysis 6.24

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 24 Fetal death.

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Analysis 6.25

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 25 Neonatal death.

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Analysis 6.26

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 26 Admission to NICU.

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Analysis 6.27

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 27 Perinatal death.

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Analysis 6.28

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 28 Preterm birth less than 34 weeks.

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Analysis 6.29

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 29 Preterm PROM.

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Analysis 6.30

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 30 Caesarean section.

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Analysis 6.31

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 31 Antenatal tocolysis.

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Analysis 6.32

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 32 Antenatal corticosteroids.

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Analysis 6.33

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 33 Preterm birth less than 37 weeks.

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Analysis 6.34

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 34 Preterm birth less than 28 weeks.

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Analysis 6.35

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 35 Infant birthweight less than 2500 g.

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Analysis 6.36

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 36 Apgar score < 7 at 5 minutes.

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Analysis 6.37

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 37 Use of assisted ventilation.

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Analysis 6.38

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 38 Fetal death.

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Analysis 6.39

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 39 Neonatal death.

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Analysis 6.40

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 40 Admission to NICU.

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Analysis 6.41

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 41 Sensitivity analysis for perinatal death (assuming total non‐independence).

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Analysis 6.42

Comparison 6 Progesterone versus placebo: multiple pregnancy, Outcome 42 Sensitivity analysis for perinatal death (assuming 1% non‐independence).

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Analysis 7.1

Comparison 7 Progesterone versus placebo: multiple pregnancy, by timing of commencement (< 20 wk v > 20 wk), Outcome 1 Preterm birth < 37 weeks.

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Analysis 7.2

Comparison 7 Progesterone versus placebo: multiple pregnancy, by timing of commencement (< 20 wk v > 20 wk), Outcome 2 Neonatal death.

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Analysis 7.3

Comparison 7 Progesterone versus placebo: multiple pregnancy, by timing of commencement (< 20 wk v > 20 wk), Outcome 3 Admission to NICU.

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Analysis 8.1

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 1 Perinatal death.

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Analysis 8.2

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 2 Preterm birth less than 34 weeks.

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Analysis 8.3

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 3 Antenatal tocolysis.

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Analysis 8.4

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 4 Preterm birth less than 37 weeks.

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Analysis 8.5

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 5 Infant birthweight less than 2500 g.

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Analysis 8.6

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 6 Respiratory distress syndrome.

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Analysis 8.7

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 7 Fetal death.

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Analysis 8.8

Comparison 8 Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 8 Admission to NICU.

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Analysis 9.1

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 1 Perinatal death.

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Analysis 9.2

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 2 Preterm birth less than 34 weeks' gestation.

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Analysis 9.3

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 3 Pregnancy prolongation (days).

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Analysis 9.4

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 4 Pregnancy prolongation ‐ less than 1 week.

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Analysis 9.5

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 5 Pregnancy prolongation ‐ 1.0 to 1.9 weeks.

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Analysis 9.6

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 6 Pregnancy prolongation ‐ 2 weeks or more.

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Analysis 9.7

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 7 Spontaneous birth.

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Analysis 9.8

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 8 Caesarean section.

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Analysis 9.9

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 9 Use of tocolysis.

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Analysis 9.10

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 10 Preterm birth less than 37 weeks' gestation.

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Analysis 9.11

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 11 Infant birthweight less than 2500 g.

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Analysis 9.12

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 12 Respiratory distress syndrome.

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Analysis 9.13

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 13 Intraventricular haemorrhage grade III or IV.

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Analysis 9.14

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 14 Periventricular leucomalacia.

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Analysis 9.15

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 15 Use of assisted ventilation.

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Analysis 9.16

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 16 Necrotizing enterocolitis.

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Analysis 9.17

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 17 Neonatal sepsis.

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Analysis 9.18

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 18 Fetal death.

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Analysis 9.19

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 19 Neonatal death.

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Analysis 9.20

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 20 Neonatal length of hospital stay (days).

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Analysis 9.21

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 21 Apgar score less than seven at five minutes.

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Analysis 9.22

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 22 Prelabour spontaneous rupture of membranes.

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Analysis 9.23

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 23 Preterm birth less than 28 weeks' gestation.

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Analysis 9.24

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 24 Apgar score less than seven at five minutes.

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Analysis 9.25

Comparison 9 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, Outcome 25 Admission to neonatal intensive care unit.

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Analysis 10.1

Comparison 10 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 1 Pregnancy prolongation (days).

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Analysis 10.2

Comparison 10 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 2 Preterm birth less than 37 weeks' gestation.

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Analysis 10.3

Comparison 10 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 3 Respiratory distress syndrome.

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Analysis 10.4

Comparison 10 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 4 Neonatal sepsis.

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Analysis 10.5

Comparison 10 Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, by cumulative weekly dose (< 500 mg v >= 500 mg), Outcome 5 Neonatal death.

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Analysis 11.1

Comparison 11 Progesterone versus placebo: other reason at risk of preterm birth, singletons, Outcome 1 Perinatal death.

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Analysis 11.2

Comparison 11 Progesterone versus placebo: other reason at risk of preterm birth, singletons, Outcome 2 Preterm birth less than 34 weeks.

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Analysis 11.3

Comparison 11 Progesterone versus placebo: other reason at risk of preterm birth, singletons, Outcome 3 Preterm birth less than 37 weeks.

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Analysis 11.4

Comparison 11 Progesterone versus placebo: other reason at risk of preterm birth, singletons, Outcome 4 Infant birthweight less than 2500 g.

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Analysis 11.5

Comparison 11 Progesterone versus placebo: other reason at risk of preterm birth, singletons, Outcome 5 Intrauterine fetal death.

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Analysis 11.6

Comparison 11 Progesterone versus placebo: other reason at risk of preterm birth, singletons, Outcome 6 Neonatal death.

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Analysis 11.7

Comparison 11 Progesterone versus placebo: other reason at risk of preterm birth, singletons, Outcome 7 Admission to neonatal intensive care unit.

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Analysis 12.1

Comparison 12 Progesterone versus placebo: other reason at risk of preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons), Outcome 1 Perinatal death.

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Analysis 12.2

Comparison 12 Progesterone versus placebo: other reason at risk of preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons), Outcome 2 Preterm birth less than 37 weeks.

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Analysis 12.3

Comparison 12 Progesterone versus placebo: other reason at risk of preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons), Outcome 3 Infant birthweight less than 2500 g.

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Comparison 1. Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal mortality Show forest plot	6	1453	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.33, 0.75]

1.1 Intramuscular	3	553	Risk Ratio (M‐H, Fixed, 95% CI)	0.41 [0.23, 0.73]
1.2 Vaginal	2	752	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.34, 1.29]
1.3 Oral	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.12, 1.59]
2 Preterm birth less than 34 weeks Show forest plot	5	602	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.14, 0.69]

2.1 Intramuscular	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Vaginal	4	454	Risk Ratio (M‐H, Random, 95% CI)	0.21 [0.10, 0.44]
2.3 Oral	1	148	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.39, 0.90]
3 Preterm birth less than 37 weeks Show forest plot	10	1750	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.42, 0.74]

3.1 Intramuscular	4	652	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.52, 0.75]
3.2 Vaginal	5	1065	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.29, 0.92]
3.3 Oral	1	33	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.19, 1.11]
4 Threatened preterm labour Show forest plot	2	601	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.47, 1.62]

4.1 Intramuscular	1	459	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.73, 1.87]
4.2 Vaginal	1	142	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.35, 1.11]
5 Spontaneous vaginal delivery Show forest plot	2	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.97, 1.18]

5.1 Vaginal	2	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.97, 1.18]
6 Caesarean section Show forest plot	3	1170	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.81, 1.20]

6.1 Intramuscular	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.68, 1.30]
6.2 Vaginal	2	711	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.79, 1.30]
7 Antenatal corticosteroids Show forest plot	2	1070	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.73, 1.16]

7.1 Intramuscular	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.58, 1.30]
7.2 Vaginal	1	611	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.72, 1.26]
8 Antenatal tocolysis Show forest plot	4	1262	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.78, 1.35]

8.1 Intramuscular	2	503	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.73, 1.72]
8.2 Vaginal	1	611	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.70, 1.74]
8.3 Oral	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.42, 1.35]
9 Infant birthweight less than 2500 g Show forest plot	4	692	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.42, 0.79]

9.1 Intramuscular	3	551	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.49, 0.81]
9.2 Vaginal	1	141	Risk Ratio (M‐H, Random, 95% CI)	0.22 [0.07, 0.74]
10 Respiratory distress syndrome Show forest plot	3	1217	Risk Ratio (M‐H, Random, 95% CI)	0.45 [0.17, 1.16]

10.1 Intramuscular	1	458	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.38, 1.04]
10.2 Vaginal	1	611	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.59, 1.43]
10.3 Oral	1	148	Risk Ratio (M‐H, Random, 95% CI)	0.10 [0.03, 0.30]
11 Use of assisted ventilation Show forest plot	3	633	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.18, 0.90]

11.1 Intramuscular	1	459	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.35, 1.01]
11.2 Oral	1	33	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.01, 1.92]
11.3 Vaginal	1	141	Risk Ratio (M‐H, Random, 95% CI)	0.24 [0.07, 0.81]
12 Intraventricular haemorrhage ‐ all grades Show forest plot	3	1211	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.20, 2.46]

12.1 Intramuscular	1	459	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.08, 0.82]
12.2 Vaginal	2	752	Risk Ratio (M‐H, Random, 95% CI)	1.31 [0.46, 3.77]
13 Intraventricular haemorrhage ‐ grade III or IV Show forest plot	2	1069	Risk Ratio (M‐H, Fixed, 95% CI)	1.59 [0.21, 11.75]

13.1 Intramuscular	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	2.52 [0.12, 52.09]
13.2 Vaginal	1	611	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.06, 15.55]
14 Periventricular leucomalacia Show forest plot	1	141	Risk Ratio (M‐H, Fixed, 95% CI)	3.13 [0.13, 75.52]

14.1 Vaginal	1	141	Risk Ratio (M‐H, Fixed, 95% CI)	3.13 [0.13, 75.52]
15 Retinopathy of prematurity Show forest plot	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.15, 1.69]

15.1 Intramuscular	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.15, 1.69]
16 Necrotising enterocolitis Show forest plot	3	1170	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.10, 0.89]

16.1 Intramuscular	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.06 [0.00, 1.03]
16.2 Vaginal	2	711	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.15, 1.92]
17 Neonatal sepsis Show forest plot	3	700	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.08, 2.23]

17.1 Intramuscular	1	459	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.35, 3.59]
17.2 Vaginal	2	241	Risk Ratio (M‐H, Random, 95% CI)	0.13 [0.02, 1.01]
18 Patent ductus arteriosus Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.16, 1.18]

18.1 Intramuscular	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.16, 1.18]
19 Intrauterine fetal death Show forest plot	4	1164	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.26, 1.69]

19.1 Intramuscular	3	553	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.14, 1.69]
19.2 Vaginal	1	611	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.33, 4.51]
20 Neonatal death Show forest plot	6	1453	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.27, 0.76]

20.1 Intramuscular	3	553	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.17, 0.87]
20.2 Vaginal	2	752	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.24, 1.18]
20.3 Oral	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.12, 1.59]
21 Developmental delay Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.36, 2.04]

21.1 Intramuscular	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.36, 2.04]
22 Intellectual impairment Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.05, 31.34]

22.1 Intramuscular	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.05, 31.34]
23 Motor Impairment Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.11, 3.76]

23.1 Intramuscular	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.11, 3.76]
24 Visual Impairment Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.16, 4.57]

24.1 Intramuscular	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.16, 4.57]
25 Hearing Impairment Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.09, 1.24]

25.1 Intramuscular	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.09, 1.24]
26 Cerebral palsy Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 3.48]

26.1 Intramuscular	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 3.48]
27 Learning difficulties Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.38, 1.92]

27.1 Intramuscular	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.38, 1.92]
28 Height less than 5th centile Show forest plot	1	270	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.23, 2.49]

28.1 Intramuscular	1	270	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.23, 2.49]
29 Weight less than 5th centile Show forest plot	1	270	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.30, 2.05]

29.1 Intramuscular	1	270	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.30, 2.05]
30 Adverse drug reaction Show forest plot	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.24, 2.15]

30.1 Oral	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.24, 2.15]
31 Pregnancy prolongation (weeks) Show forest plot	1	148	Mean Difference (IV, Fixed, 95% CI)	4.47 [2.15, 6.79]

31.1 Oral	1	148	Mean Difference (IV, Fixed, 95% CI)	4.47 [2.15, 6.79]
32 Apgar score < 7 Show forest plot	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.24, 1.25]

32.1 Intramuscular	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.24, 1.25]
33 Admission to neonatal intensive care unit Show forest plot	3	389	Risk Ratio (M‐H, Fixed, 95% CI)	0.24 [0.14, 0.40]

33.1 Oral	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.14, 0.49]
33.2 Vaginal	2	241	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.09, 0.49]
34 Neonatal length of hospital stay (days) Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	‐1.0 [‐7.67, 5.67]

34.1 Oral	1	33	Mean Difference (IV, Fixed, 95% CI)	‐1.0 [‐7.67, 5.67]
35 Infant weight at 6 months follow‐up (g) Show forest plot	1	436	Mean Difference (IV, Fixed, 95% CI)	29.0 [‐209.62, 267.62]

35.1 Vaginal	1	436	Mean Difference (IV, Fixed, 95% CI)	29.0 [‐209.62, 267.62]
36 Infant weight at 12 months follow‐up (g) Show forest plot	1	379	Mean Difference (IV, Fixed, 95% CI)	‐88.0 [‐381.48, 205.48]

36.1 Vaginal	1	379	Mean Difference (IV, Fixed, 95% CI)	‐88.0 [‐381.48, 205.48]
37 Infant weight at 24 months follow‐up (g) Show forest plot	1	287	Mean Difference (IV, Fixed, 95% CI)	‐40.0 [‐482.41, 402.41]

37.1 Vaginal	1	287	Mean Difference (IV, Fixed, 95% CI)	‐40.0 [‐482.41, 402.41]
38 Infant length at 6 months follow‐up (cm) Show forest plot	1	430	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.59, 0.79]

38.1 Vaginal	1	430	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.59, 0.79]
39 Infant length at 12 months follow‐up (cm) Show forest plot	1	376	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.80, 0.60]

39.1 Vaginal	1	376	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.80, 0.60]
40 Infant length at 24 months follow‐up (cm) Show forest plot	1	284	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐1.23, 0.83]

40.1 Vaginal	1	284	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐1.23, 0.83]
41 Infant head circumference at 6 months follow‐up (cm) Show forest plot	1	426	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.23, 0.43]

41.1 Vaginal	1	426	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.23, 0.43]
42 Infant head circumference at 12 months follow‐up (cm) Show forest plot	1	372	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.26, 0.46]

42.1 Vaginal	1	372	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.26, 0.46]
43 Infant head circumference at 24 months follow‐up (cm) Show forest plot	1	264	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.21, 0.61]

43.1 Vaginal	1	264	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐0.21, 0.61]

Comparison 1. Progesterone versus placebo/no treatment: previous history spontaneous preterm birth (singletons)

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Comparison 2. Progesterone versus placebo/no treatment: previous history spontaneous preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Preterm birth less than 37 weeks Show forest plot	6	1360	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.44, 0.89]

1.1 Therapy commences before 20 weeks	4	1147	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.46, 1.04]
1.2 Therapy commences after 20 weeks	2	213	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.30, 0.78]

Comparison 2. Progesterone versus placebo/no treatment: previous history spontaneous preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons)

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Comparison 3. Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	5	1403	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.35, 0.97]

1.1 Dose < 500 mg per week	2	503	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.07, 2.18]
1.2 Dose >= 500 mg per week	3	900	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.29, 1.21]
2 Preterm birth less than 37 weeks Show forest plot	9	1700	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.40, 0.74]

2.1 Dose < 500 mg per week	3	602	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.44, 0.80]
2.2 Dose >= 500 mg per week	6	1098	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.31, 0.85]
3 Threatened preterm labour Show forest plot	2	601	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.47, 1.62]

3.1 Dose < 500 mg per week	1	459	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.73, 1.87]
3.2 Dose >= 500 mg per week	1	142	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.35, 1.11]
4 Caesarean section Show forest plot	3	1170	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.72, 1.13]

4.1 Dose < 500 mg per week	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.58, 1.30]
4.2 Dose >= 500 mg per week	2	711	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.70, 1.21]
5 Antenatal corticosteroids Show forest plot	2	1070	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.73, 1.16]

5.1 Dose < 500 mg per week	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.58, 1.30]
5.2 Dose >= 500 mg per week	1	611	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.72, 1.26]
6 Need for tocolysis Show forest plot	3	1114	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.81, 1.52]

6.1 Dose < 500 mg per week	2	503	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.73, 1.72]
6.2 Dose >= 500 mg per week	1	611	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.70, 1.74]
7 Respiratory distress syndrome Show forest plot	4	1359	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.16, 0.89]

7.1 Dose < 500 mg per week	1	459	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.38, 1.05]
7.2 Dose >= 500 mg per week	3	900	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.07, 1.23]
8 Intraventricular haemorrhage ‐ all grades Show forest plot	3	1211	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.20, 2.46]

8.1 Dose < 500 mg per week	1	459	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.08, 0.82]
8.2 Dose >= 500 mg per week	2	752	Risk Ratio (M‐H, Random, 95% CI)	1.31 [0.46, 3.77]
9 Intraventricular haemorrhage ‐ grade III or IV Show forest plot	2	1070	Risk Ratio (M‐H, Fixed, 95% CI)	1.59 [0.21, 11.73]

9.1 Dose < 500 mg per week	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	2.51 [0.12, 51.92]
9.2 Dose >= 500 mg per week	1	611	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.06, 15.55]
10 Necrotising enterocolitis Show forest plot	3	1170	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.10, 1.25]

10.1 Dose < 500 mg per week	1	459	Risk Ratio (M‐H, Random, 95% CI)	0.06 [0.00, 1.03]
10.2 Dose >= 500 mg per week	2	711	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.15, 1.95]
11 Intrauterine fetal death Show forest plot	3	1114	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.32, 2.91]

11.1 Dose < 500 mg per week	2	503	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.05, 6.51]
11.2 Dose >= 500 mg per week	1	611	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.33, 4.51]
12 Neonatal death Show forest plot	5	1403	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.28, 0.81]

12.1 Dose < 500 mg per week	2	503	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.17, 1.03]
12.2 Dose >= 500 mg per week	3	900	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.26, 0.99]

Comparison 3. Progesterone versus placebo/no treatment: previous history spontaneous preterm birth by cumulative weekly dose (< 500 mg v >= 500 mg, singletons)

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Comparison 4. Progesterone versus placebo: ultrasound identified short cervix, singletons

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	3	1389	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.42, 1.29]

1.1 Vaginal	2	732	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.27, 1.17]
1.2 Intramuscular	1	657	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.46, 2.72]
2 Preterm birth less than 34 weeks Show forest plot	2	438	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.90]

2.1 Vaginal	1	250	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.38, 0.87]
2.2 Intramuscular	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.43, 1.46]
3 Preterm labour Show forest plot	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.63, 1.74]

3.1 Intramuscular	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.63, 1.74]
4 Prelabour spontaneous rupture of membranes Show forest plot	2	845	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.68, 2.62]

4.1 Intramuscular	2	845	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.68, 2.62]
5 Side effects (any) Show forest plot	2	842	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.92, 1.13]

5.1 Intramuscular	2	842	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.92, 1.13]
6 Side effects (injection site) Show forest plot	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.93, 1.17]

6.1 Intramuscular	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.93, 1.17]
7 Side effects (urticaria) Show forest plot	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	5.03 [1.11, 22.78]

7.1 Intramuscular	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	5.03 [1.11, 22.78]
8 Side effects (nausea) Show forest plot	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.27, 1.83]

8.1 Intramuscular	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.27, 1.83]
9 Pregnancy prolongation (days) Show forest plot	1	188	Mean Difference (IV, Fixed, 95% CI)	‐2.0 [‐10.29, 6.29]

9.1 Intramuscular	1	188	Mean Difference (IV, Fixed, 95% CI)	‐2.0 [‐10.29, 6.29]
10 Caesarean section Show forest plot	2	838	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.79, 1.40]

10.1 Intramuscular	2	838	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.79, 1.40]
11 Antenatal tocolysis Show forest plot	2	828	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.60, 1.11]

11.1 Intramuscular	2	828	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.60, 1.11]
12 Preterm birth less than 37 weeks Show forest plot	3	1303	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.82, 1.15]

12.1 Vaginal	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.68, 1.16]
12.2 Intramuscular	2	845	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.83, 1.28]
13 Preterm birth less than 28 weeks Show forest plot	2	1115	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.37, 0.93]

13.1 Vaginal	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.25, 0.97]
13.2 Intramuscular	1	657	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.36, 1.30]
14 Infant birthweight less than 2500 g Show forest plot	3	1379	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.78, 1.09]

14.1 Vaginal	2	728	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.73, 1.09]
14.2 Intramuscular	1	651	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.73, 1.30]
15 Respiratory distress syndrome Show forest plot	4	1556	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.48, 1.00]

15.1 Vaginal	2	732	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.29, 0.85]
15.2 Intramuscular	2	824	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.58, 1.58]
16 Apgar score < 7 Show forest plot	1	651	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.41, 1.55]

16.1 Intramuscular	1	651	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.41, 1.55]
17 Need for assisted ventilation Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.36, 1.16]

17.1 Vaginal	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.36, 1.16]
18 Intraventricular haemorrhage ‐ all grades Show forest plot	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.05, 5.53]

18.1 Vaginal	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.05, 5.53]
19 Intraventricular haemorrhage ‐ grades III or IV Show forest plot	2	1100	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.17, 5.60]

19.1 Vaginal	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.73]
19.2 Intramuscular	1	642	Risk Ratio (M‐H, Fixed, 95% CI)	2.01 [0.18, 22.08]
20 Periventricular leucomalacia Show forest plot	3	1282	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.38, 8.24]

20.1 Vaginal	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
20.2 Intramuscular	2	824	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.38, 8.24]
21 Retinopathy of prematurity Show forest plot	2	916	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.23, 4.42]

21.1 Vaginal	1	274	Risk Ratio (M‐H, Fixed, 95% CI)	5.07 [0.25, 104.70]
21.2 Intramuscular	1	642	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.04, 3.21]
22 Necrotising enterocolitis Show forest plot	3	1374	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.27, 1.78]

22.1 Vaginal	2	732	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.30, 3.11]
22.2 Intramuscular	1	642	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.08, 2.06]
23 Neonatal sepsis Show forest plot	3	1374	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.18, 1.20]

23.1 Vaginal	2	732	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.15, 2.25]
23.2 Intramuscular	1	642	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.08, 0.97]
24 Intrauterine fetal death Show forest plot	3	1389	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.48, 3.04]

24.1 Vaginal	2	732	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.28, 2.42]
24.2 Intramuscular	1	657	Risk Ratio (M‐H, Fixed, 95% CI)	4.04 [0.45, 35.92]
25 Neonatal death Show forest plot	4	1571	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.26, 1.13]

25.1 Vaginal	2	732	Risk Ratio (M‐H, Fixed, 95% CI)	0.41 [0.15, 1.15]
25.2 Intramuscular	2	839	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.27, 2.16]
26 Admission to neonatal intensive care unit Show forest plot	2	834	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.79, 1.35]

26.1 Intramuscular	2	834	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.79, 1.35]

Comparison 4. Progesterone versus placebo: ultrasound identified short cervix, singletons

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Comparison 5. Progesterone versus placebo: ultrasound identified short cervix, singletons by cumulative weekly dose (<500 mg v >=500 mg)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Periventricular leucomalacia Show forest plot	2	824	Risk Ratio (M‐H, Random, 95% CI)	1.49 [0.13, 16.87]

1.1 Dose < 500 mg per week	1	642	Risk Ratio (M‐H, Random, 95% CI)	4.03 [0.45, 35.81]
1.2 Dose >= 500 mg per week	1	182	Risk Ratio (M‐H, Random, 95% CI)	0.32 [0.01, 7.73]
2 Admission to neonatal intensive care unit Show forest plot	2	834	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.72, 1.65]

2.1 Dose < 500 mg per week	1	651	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.69, 1.27]
2.2 Dose >= 500 mg per week	1	183	Risk Ratio (M‐H, Random, 95% CI)	1.45 [0.83, 2.55]

Comparison 5. Progesterone versus placebo: ultrasound identified short cervix, singletons by cumulative weekly dose (<500 mg v >=500 mg)

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Comparison 6. Progesterone versus placebo: multiple pregnancy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	7	4136	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.45, 1.94]

1.1 Intramuscular	4	2228	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.30, 3.71]
1.2 Vaginal	3	1908	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.24, 2.41]
2 Preterm birth less than 34 weeks Show forest plot	6	1758	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.74, 1.27]

2.1 Vaginal	5	1520	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.69, 1.23]
2.2 Intramuscular	1	238	Risk Ratio (M‐H, Random, 95% CI)	1.37 [0.73, 2.59]
3 Preterm PROM Show forest plot	3	995	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.74, 1.70]

3.1 Intramuscular	2	802	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.72, 1.71]
3.2 Vaginal	1	193	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.30, 5.74]
4 Adverse drug reaction Show forest plot	2	1162	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.64, 1.19]

4.1 Intramuscular	1	668	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.54, 1.01]
4.2 Vaginal	1	494	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.89, 1.08]
5 Caesarean section Show forest plot	8	3136	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.91, 1.02]

5.1 Intramuscular	5	1773	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.94, 1.09]
5.2 Vaginal	3	1363	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.84, 0.98]
6 Spontaneous birth Show forest plot	2	1168	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.62, 2.38]

6.1 Intramuscular	1	668	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.75, 1.04]
6.2 Vaginal	1	500	Risk Ratio (M‐H, Random, 95% CI)	1.74 [1.21, 2.49]
7 Assisted birth Show forest plot	2	1168	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.57, 1.76]

7.1 Intramuscular	1	668	Risk Ratio (M‐H, Random, 95% CI)	1.31 [0.86, 1.99]
7.2 Vaginal	1	500	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.44, 1.24]
8 Satisfaction with therapy Show forest plot	1	494	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.35, 0.35]

8.1 Vaginal	1	494	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.35, 0.35]
9 Antenatal tocolysis Show forest plot	7	2642	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.80, 1.10]

9.1 Intramuscular	5	1775	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.82, 1.17]
9.2 Vaginal	2	867	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.55, 1.03]
10 Antenatal corticosteroids Show forest plot	2	847	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.77, 1.26]

10.1 Intramuscular	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.70, 1.17]
10.2 Vaginal	1	193	Risk Ratio (M‐H, Fixed, 95% CI)	1.68 [0.81, 3.49]
11 Preterm birth less than 37 weeks Show forest plot	8	2674	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.95, 1.14]

11.1 Intramuscular	4	1638	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.96, 1.22]
11.2 Vaginal	4	1036	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.85, 1.13]
12 Preterm birth less than 28 weeks Show forest plot	5	1855	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.75, 1.95]

12.1 Intramuscular	3	987	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.68, 2.07]
12.2 Vaginal	2	868	Risk Ratio (M‐H, Fixed, 95% CI)	1.27 [0.51, 3.19]
13 Infant birthweight less than 2500 g Show forest plot	7	5404	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.88, 1.03]

13.1 Intramuscular	4	3502	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.91, 1.14]
13.2 Vaginal	3	1902	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.80, 0.94]
14 Apgar score < 7 at 5 minutes Show forest plot	4	3451	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.66, 1.21]

14.1 Intramuscular	2	1750	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.70, 1.38]
14.2 Vaginal	2	1701	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.28, 1.23]
15 Respiratory distress syndrome Show forest plot	6	5065	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.94, 1.35]

15.1 Intramuscular	5	3732	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.91, 1.42]
15.2 Vaginal	1	1333	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.79, 1.48]
16 Use of assisted ventilation Show forest plot	4	3392	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.78, 1.16]

16.1 Intramuscular	2	1675	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.80, 1.22]
16.2 Vaginal	2	1717	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.45, 1.36]
17 Intraventricular haemorrhage ‐ grades III or IV Show forest plot	4	2368	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.45, 1.92]

17.1 Intramuscular	4	2368	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.45, 1.92]
18 Intraventricular haemorrhage ‐ all grades Show forest plot	2	2688	Risk Ratio (M‐H, Fixed, 95% CI)	1.77 [0.75, 4.21]

18.1 Intramuscular	1	1355	Risk Ratio (M‐H, Fixed, 95% CI)	1.98 [0.36, 10.77]
18.2 Vaginal	1	1333	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [0.62, 4.66]
19 Periventricular leucomalacia Show forest plot	3	1091	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.05, 3.02]

19.1 Intramuscular	3	1091	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.05, 3.02]
20 Retinopathy of prematurity Show forest plot	5	3668	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.32, 1.91]

20.1 Intramuscular	4	2335	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.20, 2.06]
20.2 Vaginal	1	1333	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.26, 4.07]
21 Chronic lung disease Show forest plot	2	681	Risk Ratio (M‐H, Random, 95% CI)	1.91 [0.13, 27.80]

21.1 Intramuscular	2	681	Risk Ratio (M‐H, Random, 95% CI)	1.91 [0.13, 27.80]
22 Necrotising enterocolitis Show forest plot	6	5059	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.50, 1.75]

22.1 Intramuscular	5	3726	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.52, 1.88]
22.2 Vaginal	1	1333	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.05, 5.63]
23 Neonatal sepsis Show forest plot	6	5065	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.89, 1.62]

23.1 Intramuscular	5	3732	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.87, 1.72]
23.2 Vaginal	1	1333	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.61, 2.13]
24 Fetal death Show forest plot	6	4788	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.71, 2.09]

24.1 Intramuscular	3	2074	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [0.77, 3.12]
24.2 Vaginal	3	2714	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.35, 1.95]
25 Neonatal death Show forest plot	7	5170	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.48, 2.10]

25.1 Intramuscular	4	2456	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.31, 2.10]
25.2 Vaginal	3	2714	Risk Ratio (M‐H, Random, 95% CI)	1.34 [0.36, 4.95]
26 Admission to NICU Show forest plot	5	4251	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.76, 1.18]

26.1 Vaginal	4	2896	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.71, 1.07]
26.2 Intramuscular	1	1355	Risk Ratio (M‐H, Random, 95% CI)	1.31 [1.05, 1.62]
27 Perinatal death Show forest plot	7	4133	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.61, 2.08]

27.1 Intramuscular	4	2228	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.30, 3.71]
27.2 Vaginal	3	1905	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.67, 2.35]
28 Preterm birth less than 34 weeks Show forest plot	6	1758	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.71, 1.24]

28.1 Vaginal	5	1520	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.65, 1.19]
28.2 Intramuscular	1	238	Risk Ratio (M‐H, Random, 95% CI)	1.37 [0.73, 2.59]
29 Preterm PROM Show forest plot	3	995	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.69, 1.60]

29.1 Intramuscular	2	802	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.72, 1.71]
29.2 Vaginal	1	193	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.03, 3.12]
30 Caesarean section Show forest plot	8	3136	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.91, 1.01]

30.1 Intramuscular	5	1773	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.94, 1.09]
30.2 Vaginal	3	1363	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.84, 0.98]
31 Antenatal tocolysis Show forest plot	7	2642	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.80, 1.10]

31.1 Intramuscular	5	1775	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.82, 1.17]
31.2 Vaginal	2	867	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.56, 1.05]
32 Antenatal corticosteroids Show forest plot	2	847	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.76, 1.24]

32.1 Intramuscular	1	654	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.70, 1.17]
32.2 Vaginal	1	193	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.76, 3.31]
33 Preterm birth less than 37 weeks Show forest plot	8	2674	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.95, 1.13]

33.1 Intramuscular	4	1638	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.96, 1.22]
33.2 Vaginal	4	1036	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.84, 1.11]
34 Preterm birth less than 28 weeks Show forest plot	5	1855	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.80, 2.04]

34.1 Intramuscular	3	987	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.68, 2.07]
34.2 Vaginal	2	868	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [0.63, 3.69]
35 Infant birthweight less than 2500 g Show forest plot	7	5401	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.89, 1.04]

35.1 Intramuscular	4	3502	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.91, 1.14]
35.2 Vaginal	3	1899	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.82, 0.96]
36 Apgar score < 7 at 5 minutes Show forest plot	4	3448	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.70, 1.27]

36.1 Intramuscular	2	1750	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.70, 1.38]
36.2 Vaginal	2	1698	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.41, 1.58]
37 Use of assisted ventilation Show forest plot	4	3389	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.81, 1.19]

37.1 Intramuscular	2	1675	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.80, 1.22]
37.2 Vaginal	2	1714	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.55, 1.59]
38 Fetal death Show forest plot	6	4785	Risk Ratio (M‐H, Fixed, 95% CI)	1.35 [0.79, 2.29]

38.1 Intramuscular	3	2074	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [0.77, 3.12]
38.2 Vaginal	3	2711	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.49, 2.48]
39 Neonatal death Show forest plot	7	5167	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.62, 2.21]

39.1 Intramuscular	4	2456	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.31, 2.10]
39.2 Vaginal	3	2711	Risk Ratio (M‐H, Random, 95% CI)	1.77 [0.84, 3.72]
40 Admission to NICU Show forest plot	5	4248	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.75, 1.17]

40.1 Vaginal	4	2893	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.70, 1.07]
40.2 Intramuscular	1	1355	Risk Ratio (M‐H, Random, 95% CI)	1.31 [1.05, 1.62]
41 Sensitivity analysis for perinatal death (assuming total non‐independence) Show forest plot	7	2068	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.43, 1.65]

41.1 Intramuscular	4	1114	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.29, 3.36]
41.2 Vaginal	3	954	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.28, 2.07]
42 Sensitivity analysis for perinatal death (assuming 1% non‐independence) Show forest plot	7	4091	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.44, 1.90]

42.1 Intramuscular	4	2203	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.29, 3.58]
42.2 Vaginal	3	1888	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.24, 2.41]

Comparison 6. Progesterone versus placebo: multiple pregnancy

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Comparison 7. Progesterone versus placebo: multiple pregnancy, by timing of commencement (< 20 wk v > 20 wk)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Preterm birth < 37 weeks Show forest plot	4	1467	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.82, 1.20]

1.1 Supplementation commenced prior to 20 weeks' gestation	2	1323	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.17]
1.2 Supplementation commenced after 20 weeks' gestation	2	144	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.38, 2.54]
2 Neonatal death Show forest plot	3	2738	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.47, 1.93]

2.1 Supplementation commenced prior to 20 weeks' gestation	2	1750	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.29, 2.91]
2.2 Supplementation commenced after 20 weeks' gestation	1	988	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.47, 3.81]
3 Admission to NICU Show forest plot	2	2343	Risk Ratio (M‐H, Random, 95% CI)	1.16 [0.95, 1.43]

3.1 Supplementation commenced prior to 20 weeks' gestation	1	988	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.88, 1.26]
3.2 Supplementation commenced after 20 weeks' gestation	1	1355	Risk Ratio (M‐H, Random, 95% CI)	1.31 [1.05, 1.62]

Comparison 7. Progesterone versus placebo: multiple pregnancy, by timing of commencement (< 20 wk v > 20 wk)

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Comparison 8. Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	7	4136	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.45, 1.94]

1.1 Dose < 500 mg per week	4	2228	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.30, 3.71]
1.2 Dose >= 500 mg per week	3	1908	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.24, 2.41]
2 Preterm birth less than 34 weeks Show forest plot	6	1758	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.74, 1.27]

2.1 Dose < 500 mg per week	1	238	Risk Ratio (M‐H, Random, 95% CI)	1.37 [0.73, 2.59]
2.2 Dose > 500 mg per week	5	1520	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.69, 1.23]
3 Antenatal tocolysis Show forest plot	7	2642	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.80, 1.10]

3.1 Dose < 500 mg per week	5	1775	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.82, 1.17]
3.2 Dose >= 500 mg per week	2	867	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.55, 1.03]
4 Preterm birth less than 37 weeks Show forest plot	8	3489	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.88, 1.06]

4.1 Dose < 500 mg per week	6	2380	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.88, 1.15]
4.2 Dose >= 500 mg per week	4	1109	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.80, 1.01]
5 Infant birthweight less than 2500 g Show forest plot	7	5404	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.88, 1.03]

5.1 Dose < 500 mg per week	4	3502	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.91, 1.14]
5.2 Dose >= 500 mg per week	3	1902	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.80, 0.94]
6 Respiratory distress syndrome Show forest plot	6	5065	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.94, 1.35]

6.1 Dose < 500 mg per week	5	3732	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.91, 1.42]
6.2 Dose >= 500 mg per week	1	1333	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.79, 1.48]
7 Fetal death Show forest plot	6	4788	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.51, 2.23]

7.1 Dose < 500 mg per week	3	2074	Risk Ratio (M‐H, Random, 95% CI)	2.52 [0.19, 33.68]
7.2 Dose >= 500 mg per week	3	2714	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.36, 2.16]
8 Admission to NICU Show forest plot	5	4251	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.76, 1.18]

8.1 Dose < 500 mg per week	1	1355	Risk Ratio (M‐H, Random, 95% CI)	1.31 [1.05, 1.62]
8.2 Dose >= 500 mg per week	4	2896	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.71, 1.07]

Comparison 8. Progesterone versus placebo: multiple pregnancy by cumulative weekly dose (< 500 mg v >= 500 mg)

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Comparison 9. Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	1	12	Risk Ratio (M‐H, Random, 95% CI)	2.0 [0.16, 24.33]

1.1 Intramuscular	1	12	Risk Ratio (M‐H, Random, 95% CI)	2.0 [0.16, 24.33]
2 Preterm birth less than 34 weeks' gestation Show forest plot	2	175	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.55, 1.65]

2.1 Intramuscular	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.72, 1.39]
2.2 Vaginal	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.37, 2.27]
3 Pregnancy prolongation (days) Show forest plot	2	232	Mean Difference (IV, Random, 95% CI)	1.88 [‐8.42, 12.17]

3.1 Intramuscular	1	69	Mean Difference (IV, Random, 95% CI)	‐3.30 [‐7.41, 0.81]
3.2 Vaginal	1	163	Mean Difference (IV, Random, 95% CI)	7.21 [2.39, 12.03]
4 Pregnancy prolongation ‐ less than 1 week Show forest plot	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	0.4 [0.07, 2.37]

4.1 Intramuscular	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	0.4 [0.07, 2.37]
5 Pregnancy prolongation ‐ 1.0 to 1.9 weeks Show forest plot	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.16, 24.33]

5.1 Intramuscular	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.16, 24.33]
6 Pregnancy prolongation ‐ 2 weeks or more Show forest plot	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.42, 9.42]

6.1 Intramuscular	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.42, 9.42]
7 Spontaneous birth Show forest plot	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.80, 1.49]

7.1 Intramuscular	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.80, 1.49]
8 Caesarean section Show forest plot	2	81	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.51, 1.60]

8.1 Intramuscular	2	81	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.51, 1.60]
9 Use of tocolysis Show forest plot	2	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.58, 1.65]

9.1 Intramuscular	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	1.2 [0.55, 2.62]
9.2 Vaginal	1	193	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.50, 1.73]
10 Preterm birth less than 37 weeks' gestation Show forest plot	2	223	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.20, 1.31]

10.1 Vaginal	1	163	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.55, 1.06]
10.2 Intramuscular	1	60	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.12, 0.69]
11 Infant birthweight less than 2500 g Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.28, 0.98]

11.1 Vaginal	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.28, 0.98]
12 Respiratory distress syndrome Show forest plot	4	314	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.49, 1.10]

12.1 Vaginal	2	233	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.20, 1.15]
12.2 Intramuscular	2	81	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.66, 1.12]
13 Intraventricular haemorrhage grade III or IV Show forest plot	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	9.0 [0.53, 152.93]

13.1 Intramuscular	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	9.0 [0.53, 152.93]
14 Periventricular leucomalacia Show forest plot	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

14.1 Intramuscular	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
15 Use of assisted ventilation Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.06, 1.37]

15.1 Vaginal	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.06, 1.37]
16 Necrotizing enterocolitis Show forest plot	2	81	Risk Ratio (M‐H, Fixed, 95% CI)	3.06 [0.50, 18.69]

16.1 Intramuscular	2	81	Risk Ratio (M‐H, Fixed, 95% CI)	3.06 [0.50, 18.69]
17 Neonatal sepsis Show forest plot	4	314	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.17, 1.68]

17.1 Vaginal	2	233	Risk Ratio (M‐H, Random, 95% CI)	0.26 [0.07, 1.00]
17.2 Intramuscular	2	81	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.39, 3.05]
18 Fetal death Show forest plot	2	81	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.07, 16.75]

18.1 Intramuscular	2	81	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.07, 16.75]
19 Neonatal death Show forest plot	2	175	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.05, 6.24]

19.1 Intramuscular	1	12	Risk Ratio (M‐H, Random, 95% CI)	2.0 [0.16, 24.33]
19.2 Vaginal	1	163	Risk Ratio (M‐H, Random, 95% CI)	0.17 [0.02, 1.40]
20 Neonatal length of hospital stay (days) Show forest plot	2	81	Mean Difference (IV, Fixed, 95% CI)	‐2.16 [‐15.84, 11.53]

20.1 Intramuscular	2	81	Mean Difference (IV, Fixed, 95% CI)	‐2.16 [‐15.84, 11.53]
21 Apgar score less than seven at five minutes Show forest plot	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.03, 2.27]

21.1 Vaginal	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.03, 2.27]
22 Prelabour spontaneous rupture of membranes Show forest plot	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.19, 1.45]

22.1 Vaginal	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.19, 1.45]
23 Preterm birth less than 28 weeks' gestation Show forest plot	1	193	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.06, 15.60]

23.1 Vaginal	1	193	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.06, 15.60]
24 Apgar score less than seven at five minutes Show forest plot	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.03, 2.27]

24.1 Vaginal	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.03, 2.27]
25 Admission to neonatal intensive care unit Show forest plot	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [0.27, 9.07]

25.1 Vaginal	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [0.27, 9.07]

Comparison 9. Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons

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Comparison 10. Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, by cumulative weekly dose (< 500 mg v >= 500 mg)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pregnancy prolongation (days) Show forest plot	2	232	Mean Difference (IV, Random, 95% CI)	1.88 [‐8.42, 12.17]

1.1 Dose < 500 mg per week	1	69	Mean Difference (IV, Random, 95% CI)	‐3.30 [‐7.41, 0.81]
1.2 Dose >= 500 mg per week	1	163	Mean Difference (IV, Random, 95% CI)	7.21 [2.39, 12.03]
2 Preterm birth less than 37 weeks' gestation Show forest plot	2	223	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.20, 1.31]

2.1 Dose >=500 mg per week	1	163	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.55, 1.06]
2.2 Dose <500 mg per week	1	60	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.12, 0.69]
3 Respiratory distress syndrome Show forest plot	4	314	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.49, 1.10]

3.1 Dose >=500 mg per week	2	233	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.20, 1.15]
3.2 Dose <500 mg per week	2	81	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.66, 1.12]
4 Neonatal sepsis Show forest plot	4	314	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.17, 1.68]

4.1 Dose >=500 mg per week	2	233	Risk Ratio (M‐H, Random, 95% CI)	0.26 [0.07, 1.00]
4.2 Dose <500 mg per week	2	81	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.39, 3.05]
5 Neonatal death Show forest plot	2	175	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.05, 6.24]

5.1 Dose <500 mg per week	1	12	Risk Ratio (M‐H, Random, 95% CI)	2.0 [0.16, 24.33]
5.2 Dose >=500 mg per week	1	163	Risk Ratio (M‐H, Random, 95% CI)	0.17 [0.02, 1.40]

Comparison 10. Progesterone versus placebo/no treatment: prior threatened preterm labour, singletons, by cumulative weekly dose (< 500 mg v >= 500 mg)

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Comparison 11. Progesterone versus placebo: other reason at risk of preterm birth, singletons

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	3	479	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.09, 3.00]

1.1 Intramuscular	2	264	Risk Ratio (M‐H, Random, 95% CI)	1.1 [0.23, 5.29]
1.2 Vaginal	1	215	Risk Ratio (M‐H, Random, 95% CI)	0.18 [0.02, 1.55]
2 Preterm birth less than 34 weeks Show forest plot	1	215	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.16, 3.01]

2.1 Vaginal	1	215	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.16, 3.01]
3 Preterm birth less than 37 weeks Show forest plot	3	482	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.32, 1.13]

3.1 Intramuscular	2	267	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.11, 2.56]
3.2 Vaginal	1	215	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.40, 0.98]
4 Infant birthweight less than 2500 g Show forest plot	3	482	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.25, 0.91]

4.1 Intramuscular	2	267	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.23, 1.18]
4.2 Vaginal	1	215	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.15, 1.16]
5 Intrauterine fetal death Show forest plot	1	168	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.04, 3.45]

5.1 Intramuscular	1	168	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.04, 3.45]
6 Neonatal death Show forest plot	1	168	Risk Ratio (M‐H, Fixed, 95% CI)	5.49 [0.27, 112.73]

6.1 Intramuscular	1	168	Risk Ratio (M‐H, Fixed, 95% CI)	5.49 [0.27, 112.73]
7 Admission to neonatal intensive care unit Show forest plot	1	215	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [0.71, 4.11]

7.1 Vaginal	1	215	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [0.71, 4.11]

Comparison 11. Progesterone versus placebo: other reason at risk of preterm birth, singletons

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Comparison 12. Progesterone versus placebo: other reason at risk of preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal death Show forest plot	2	264	Risk Ratio (M‐H, Fixed, 95% CI)	1.1 [0.23, 5.29]

1.1 Supplementation commenced prior to 20 weeks' gestation	1	168	Risk Ratio (M‐H, Fixed, 95% CI)	1.1 [0.23, 5.29]
1.2 Supplementation commenced after 20 weeks' gestation	1	96	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Preterm birth less than 37 weeks Show forest plot	2	267	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.11, 2.56]

2.1 Supplementation commenced prior to 20 weeks' gestation	1	168	Risk Ratio (M‐H, Random, 95% CI)	1.1 [0.33, 3.66]
2.2 Supplementation commenced after 20 weeks' gestation	1	99	Risk Ratio (M‐H, Random, 95% CI)	0.22 [0.05, 0.96]
3 Infant birthweight less than 2500 g Show forest plot	2	267	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.16, 1.65]

3.1 Supplementation commenced prior to 20 weeks' gestation	1	168	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.30, 2.27]
3.2 Supplementation commenced after 20 weeks' gestation	1	99	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.05, 1.10]

Comparison 12. Progesterone versus placebo: other reason at risk of preterm birth, by timing of commencement (< 20 wk v > 20 wk, singletons)

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