Planned early delivery versus expectant management for hypertensive disorders from 34 weeks gestation to term

Catherine Cluver; Natalia Novikova; Corine M Koopmans; Helen M West

doi:10.1002/14651858.CD009273.pub2

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Figure 1

Study flow diagram.

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Figure 2

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 3

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

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Analysis 1.1

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 1 Composite maternal mortality and morbidity.

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Analysis 1.2

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 2 Composite infant mortality and morbidity.

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Analysis 1.3

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 3 Maternal mortality.

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Analysis 1.4

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 4 Eclampsia.

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Analysis 1.5

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 5 Pulmonary oedema.

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Analysis 1.6

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 6 Severe renal impairment.

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Analysis 1.7

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 7 HELLP syndrome.

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Analysis 1.8

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 8 Thromboembolic disease.

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Analysis 1.9

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 9 Abruptio placentae.

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Analysis 1.10

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 10 Postpartum haemorrhage.

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Analysis 1.11

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 11 Severe hypertension.

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Analysis 1.12

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 12 Caesarean section.

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Analysis 1.13

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 13 Assisted delivery (ventouse/forceps).

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Analysis 1.14

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 14 Maternal morbidity of caesarean section.

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Analysis 1.15

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 15 Maternal morbidity related to induction of labour.

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Analysis 1.16

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 16 Admission to a high care or intensive care unit.

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Analysis 1.17

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 17 Fetal death.

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Analysis 1.18

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 18 Neonatal death.

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Analysis 1.19

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 19 Grade III or IV intraventricular or intracerebral haemorrhage.

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Analysis 1.20

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 20 Nectrotising enterocolitis.

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Analysis 1.21

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 21 Respiratory distress syndrome.

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Analysis 1.22

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 22 Small‐for‐gestational age.

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Analysis 1.23

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 23 Neonatal seizures.

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Analysis 1.24

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 24 Apgar score less than seven at five minutes.

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Analysis 1.25

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 25 Cord blood pH less than 7.1 or as defined by trial authors.

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Analysis 1.26

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 26 Surfactant use.

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Analysis 1.27

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 27 Neonatal intensive care unit or high care unit admission.

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Analysis 1.28

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 28 Early neonatal sepsis.

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Analysis 1.29

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 29 Duration of hospital stay after delivery for mother (days).

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Analysis 1.30

Comparison 1 Planned early delivery versus expectant management (all women), Outcome 30 Duration of hospital stay after delivery for baby (days).

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Analysis 2.1

Comparison 2 Planned early delivery versus expectant management (by gestational age), Outcome 1 Composite maternal mortality and morbidity.

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Analysis 2.2

Comparison 2 Planned early delivery versus expectant management (by gestational age), Outcome 2 Respiratory distress syndrome.

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Analysis 2.3

Comparison 2 Planned early delivery versus expectant management (by gestational age), Outcome 3 Composite infant mortality and morbidity.

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Analysis 3.1

Comparison 3 Planned early delivery versus expectant management (by each gestational week), Outcome 1 Composite maternal mortality and morbidity.

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Analysis 3.2

Comparison 3 Planned early delivery versus expectant management (by each gestational week), Outcome 2 Respiratory distress syndrome.

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Analysis 3.3

Comparison 3 Planned early delivery versus expectant management (by each gestational week), Outcome 3 Composite infant mortality and morbidity.

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Analysis 4.1

Comparison 4 Planned early delivery versus expectant management (by condition), Outcome 1 Composite maternal mortality and morbidity.

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Analysis 4.2

Comparison 4 Planned early delivery versus expectant management (by condition), Outcome 2 Respiratory distress syndrome.

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Summary of findings for the main comparison. Planned early delivery versus expectant management for hypertensive disorders from 34 weeks' gestation to term

Planned early delivery versus expectant management for hypertensive disorders from 34 weeks' gestation to term
Patient or population: pregnant women with hypertensive disorders from 34 weeks' gestation to term Setting: 2 studies in the Netherlands, 1 in India, and 1 in the USA Intervention: planned early delivery Comparison: expectant management
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with GRADE
Composite maternal mortality and morbidity	Study population		RR 0.69 (0.57 to 0.83)	1459 (2 RCTs)	⊕⊕⊕⊕ HIGH
	242 per 1000	167 per 1000 (138 to 201)
	Moderate
	235 per 1000	162 per 1000 (134 to 195)
Composite infant mortality and morbidity			not pooled	1459 (2 RCTs)		This outcome was not pooled, due to substantial statistical heterogeneity (I² = 87%, Tau² = 0.98)

Caesarean section	Study population		RR 0.91 (0.78 to 1.07)	1728 (4 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	267 per 1000	243 per 1000 (208 to 285)
	Moderate
	302 per 1000	275 per 1000 (236 to 324)
Duration of hospital stay after delivery for mother (days)	The mean duration of hospital stay after delivery for mother (days) was 0	The mean duration of hospital stay after delivery for mother (days) in the intervention group was 0.16 fewer (0.46 fewer to 0.15 more)	‐	925 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Duration of hospital stay after delivery for baby (days)	The mean duration of hospital stay after delivery for baby (days) was 0	The mean duration of hospital stay after delivery for baby (days) in the intervention group was 0.2 days fewer (0.57 fewer to 0.17 more)	‐	756 (1 RCT)	⊕⊕⊕⊝ MODERATE ¹
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹Wide confidence interval crossing the line of no effect.

Summary of findings for the main comparison. Planned early delivery versus expectant management for hypertensive disorders from 34 weeks' gestation to term

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Comparison 1. Planned early delivery versus expectant management (all women)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Composite maternal mortality and morbidity Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.57, 0.83]

2 Composite infant mortality and morbidity Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3 Maternal mortality Show forest plot	2	1457	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

4 Eclampsia Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.14]

5 Pulmonary oedema Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.17]

6 Severe renal impairment Show forest plot	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.14, 0.92]

7 HELLP syndrome Show forest plot	3	1628	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.17, 0.93]

8 Thromboembolic disease Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.22, 12.58]

9 Abruptio placentae Show forest plot	3	1535	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.17, 2.34]

10 Postpartum haemorrhage Show forest plot	1	741	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.57, 1.35]

11 Severe hypertension Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

12 Caesarean section Show forest plot	4	1728	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.78, 1.07]

13 Assisted delivery (ventouse/forceps) Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.70, 1.24]

14 Maternal morbidity of caesarean section Show forest plot	1	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.17, 3.35]

14.1 Endometritis	1	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.17, 3.35]
15 Maternal morbidity related to induction of labour Show forest plot	1	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

15.1 Uterine rupture	1	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
16 Admission to a high care or intensive care unit Show forest plot	1	708	Risk Ratio (M‐H, Fixed, 95% CI)	0.41 [0.16, 1.07]

17 Fetal death Show forest plot	1	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

18 Neonatal death Show forest plot	3	1535	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.19, 21.14]

19 Grade III or IV intraventricular or intracerebral haemorrhage Show forest plot	1	674	Risk Ratio (M‐H, Fixed, 95% CI)	6.92 [0.36, 133.41]

20 Nectrotising enterocolitis Show forest plot	2	1338	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.14, 6.89]

21 Respiratory distress syndrome Show forest plot	3	1511	Risk Ratio (M‐H, Fixed, 95% CI)	2.24 [1.20, 4.18]

22 Small‐for‐gestational age Show forest plot	3	1001	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.89, 2.79]

23 Neonatal seizures Show forest plot	1	699	Risk Ratio (M‐H, Fixed, 95% CI)	3.97 [0.45, 35.30]

24 Apgar score less than seven at five minutes Show forest plot	2	1454	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.60, 2.05]

25 Cord blood pH less than 7.1 or as defined by trial authors Show forest plot	2	1145	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.31, 1.09]

26 Surfactant use Show forest plot	1	639	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

27 Neonatal intensive care unit or high care unit admission Show forest plot	4	1585	Risk Ratio (M‐H, Fixed, 95% CI)	1.65 [1.13, 2.40]

28 Early neonatal sepsis Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

29 Duration of hospital stay after delivery for mother (days) Show forest plot	2	925	Mean Difference (IV, Fixed, 95% CI)	‐0.16 [‐0.46, 0.15]

30 Duration of hospital stay after delivery for baby (days) Show forest plot	1	756	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.57, 0.17]

Comparison 1. Planned early delivery versus expectant management (all women)

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Comparison 2. Planned early delivery versus expectant management (by gestational age)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Composite maternal mortality and morbidity Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.57, 0.83]

1.1 34 + 0 to 36 + 6 weeks GA at randomisation	2	778	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.48, 1.24]
1.2 37 + 0 to 38 + 6 weeks GA at randomisation	1	380	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.53, 0.90]
1.3 39 + 0 to 41 + 0 weeks GA at randomisation	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.88]
2 Respiratory distress syndrome Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	2.53 [1.16, 5.55]

2.1 34 + 0 to 36 + 6 weeks GA at randomisation	2	778	Risk Ratio (M‐H, Fixed, 95% CI)	3.32 [1.35, 8.18]
2.2 37 + 0 to 38 + 6 weeks GA at randomisation	1	380	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 7.72]
2.3 39 + 0 to 41 + 0 weeks GA at randomisation	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.07, 17.74]
3 Composite infant mortality and morbidity Show forest plot	1	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.46, 1.28]

3.1 36 + 0 to 36 + 6 weeks GA at randomisation	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	2.63 [0.29, 24.10]
3.2 37 + 0 to 38 + 6 weeks GA at randomisation	1	380	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.31, 1.49]
3.3 39 + 0 to 41 + 0 weeks GA at randomisation	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.35, 1.49]

Comparison 2. Planned early delivery versus expectant management (by gestational age)

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Comparison 3. Planned early delivery versus expectant management (by each gestational week)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Composite maternal mortality and morbidity Show forest plot	2	1459	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.57, 0.83]

1.1 34 + 0 to 34 + 6 weeks GA at randomisation	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	4.75 [0.23, 97.34]
1.2 35 + 0 to 35 + 6 weeks GA at randomisation	1	236	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.10]
1.3 36 + 0 to 36 + 6 weeks GA at randomisation	2	388	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.59, 1.62]
1.4 37 + 0 to 37 + 6 weeks GA at randomisation	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.52, 1.08]
1.5 38 + 0 to 38 + 6 weeks GA at randomisation	1	192	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.43, 0.94]
1.6 39 + 0 to 39 + 6 weeks GA at randomisation	1	186	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.53, 1.14]
1.7 40 + 0 to 41 + 0 weeks GA at randomisation	1	115	Risk Ratio (M‐H, Fixed, 95% CI)	0.46 [0.26, 0.79]
2 Respiratory distress syndrome Show forest plot	1	703	Risk Ratio (M‐H, Fixed, 95% CI)	3.32 [1.38, 8.01]

2.1 34 + 0 to 34 + 6 weeks GA at randomisation	1	154	Risk Ratio (M‐H, Fixed, 95% CI)	2.37 [0.78, 7.24]
2.2 35 + 0 to 35 + 6 weeks GA at randomisation	1	236	Risk Ratio (M‐H, Fixed, 95% CI)	7.62 [0.93, 62.27]
2.3 36 + 0 to 36 + 6 weeks GA at randomisation	1	313	Risk Ratio (M‐H, Fixed, 95% CI)	3.41 [0.39, 30.15]
3 Composite infant mortality and morbidity Show forest plot	1	756	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.46, 1.29]

3.1 36 + 0 to 36 + 6 weeks GA at randomisation	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	2.63 [0.29, 24.10]
3.2 37 + 0 to 37 + 6 weeks GA at randomisation	1	188	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.17, 1.35]
3.3 38 + 0 to 38 + 6 weeks GA at randomisation	1	192	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.33, 4.24]
3.4 39 + 0 to 39 + 6 weeks GA at randomisation	1	186	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.32, 1.95]
3.5 40 + 0 to 41 + 0 weeks GA at randomisation	1	115	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.19, 2.12]

Comparison 3. Planned early delivery versus expectant management (by each gestational week)

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Comparison 4. Planned early delivery versus expectant management (by condition)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Composite maternal mortality and morbidity Show forest plot	2	1445	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.58, 0.85]

1.1 Gestational hypertension	2	678	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.61, 1.00]
1.2 Mild pre‐eclampsia	2	570	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.45, 0.81]
1.3 Chronic hypertension	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.10, 2.86]
2 Respiratory distress syndrome Show forest plot	1	703	Risk Ratio (M‐H, Fixed, 95% CI)	3.36 [1.36, 8.31]

2.1 Gestational hypertension	1	182	Risk Ratio (M‐H, Fixed, 95% CI)	3.91 [0.45, 34.34]
2.2 Mild pre‐eclampsia	1	324	Risk Ratio (M‐H, Fixed, 95% CI)	4.82 [1.07, 21.65]
2.3 Chronic hypertension	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	2.15 [0.55, 8.35]

Comparison 4. Planned early delivery versus expectant management (by condition)

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