Planned early delivery versus expectant management of the term suspected compromised baby for improving outcomes

Diana M Bond; Adrienne Gordon; Jon Hyett; Bradley de Vries; Angela E Carberry; Jonathan Morris

doi:10.1002/14651858.CD009433.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, Outcome 1 Perinatal mortality.

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Analysis 1.2

Comparison 1 Planned early delivery versus expectant management, Outcome 2 Major neonatal morbidity.

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Analysis 1.3

Comparison 1 Planned early delivery versus expectant management, Outcome 3 Neurodevelopmental disability/impairment.

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Analysis 1.4

Comparison 1 Planned early delivery versus expectant management, Outcome 4 Maternal mortality.

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Analysis 1.5

Comparison 1 Planned early delivery versus expectant management, Outcome 5 Major maternal morbidity.

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Analysis 1.6

Comparison 1 Planned early delivery versus expectant management, Outcome 6 Neonatal seizures.

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Analysis 1.7

Comparison 1 Planned early delivery versus expectant management, Outcome 7 Necrotising enterocolitis.

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Analysis 1.8

Comparison 1 Planned early delivery versus expectant management, Outcome 8 Respiratory distress syndrome.

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Analysis 1.9

Comparison 1 Planned early delivery versus expectant management, Outcome 9 Meconium aspiration.

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Analysis 1.10

Comparison 1 Planned early delivery versus expectant management, Outcome 10 Gestational age at birth (days).

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Analysis 1.11

Comparison 1 Planned early delivery versus expectant management, Outcome 11 Gestational age ≥ 40 weeks (not pre‐specified).

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Analysis 1.12

Comparison 1 Planned early delivery versus expectant management, Outcome 12 Apgar score < 7 at 5 minutes.

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Analysis 1.13

Comparison 1 Planned early delivery versus expectant management, Outcome 13 Resuscitation required.

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Analysis 1.14

Comparison 1 Planned early delivery versus expectant management, Outcome 14 Requirement for mechanical ventilation.

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Analysis 1.15

Comparison 1 Planned early delivery versus expectant management, Outcome 15 Birthweight < 10 centile.

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Analysis 1.16

Comparison 1 Planned early delivery versus expectant management, Outcome 16 Birthweight < 2.3 centile (not pre‐specified).

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Analysis 1.17

Comparison 1 Planned early delivery versus expectant management, Outcome 17 Admission to NICU.

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Analysis 1.18

Comparison 1 Planned early delivery versus expectant management, Outcome 18 Admission to intermediate care nursery (not pre‐specified).

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Analysis 1.19

Comparison 1 Planned early delivery versus expectant management, Outcome 19 Length of stay in NICU/SCN (days).

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Analysis 1.20

Comparison 1 Planned early delivery versus expectant management, Outcome 20 Interval (days) between randomisation and delivery.

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Analysis 1.21

Comparison 1 Planned early delivery versus expectant management, Outcome 21 Neonatal sepsis.

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Analysis 1.22

Comparison 1 Planned early delivery versus expectant management, Outcome 22 Caesarean section.

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Analysis 1.23

Comparison 1 Planned early delivery versus expectant management, Outcome 23 Placental abruption.

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Analysis 1.24

Comparison 1 Planned early delivery versus expectant management, Outcome 24 Pre‐eclampsia.

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Analysis 1.25

Comparison 1 Planned early delivery versus expectant management, Outcome 25 Induction of labour.

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Analysis 1.26

Comparison 1 Planned early delivery versus expectant management, Outcome 26 Vaginal birth.

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Analysis 1.27

Comparison 1 Planned early delivery versus expectant management, Outcome 27 Assisted vaginal birth.

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Analysis 1.28

Comparison 1 Planned early delivery versus expectant management, Outcome 28 Breastfeeding.

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Analysis 1.29

Comparison 1 Planned early delivery versus expectant management, Outcome 29 Breastfeeding (weeks).

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Analysis 1.30

Comparison 1 Planned early delivery versus expectant management, Outcome 30 Maternal hospital stay (days) (not pre‐specified).

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Summary of findings for the main comparison. Planned early delivery compared with expectant management for improving outcomes of the term suspected compromised baby

Planned early delivery compared with expectant management for improving outcomes of the term suspected compromised baby
Patient or population: pregnant women with a term suspected compromised baby Settings: studies took place in The Netherlands and Sweden Intervention: planned early delivery Comparison: expectant management
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Expectant management	Planned early delivery
Perinatal mortality (stillbirth ‐ death of fetus prior to birth; neonatal death ‐ death within the first 28 days of birth; or infant death ‐ death after the first 28 days)	See comment	See comment	Not estimable	459 (1 study)	⊕⊕⊕⊝ moderate¹
Major neonatal morbidity one or more of the following: hypoxic ischaemic encephalopathy (HIE) ‐ grade II or III, necrotising enterocolitis (NEC), need for ongoing ventilation, meconium aspiration syndrome, seizures, need for therapeutic hypothermia Follow‐up: 0‐22 days	Study population		RR 0.15 (0.01 to 2.81)	459 (1 study)	⊕⊕⊝⊝ low^2,3
	13 per 1000	2 per 1000 (0 to 36)
Neurodevelopmental disability/impairment CBCL, Ages and Stages Questionnaire Follow‐up: mean 2 years	Study population		RR 2.04 (0.62 to 6.69)	459 (1 study)	⊕⊕⊝⊝ low^2,3
	17 per 1000	35 per 1000 (11 to 115)
Maternal mortality Follow‐up: 0‐10 days	Study population		RR 3.07 (0.13 to 74.87)	459 (1 study)	⊕⊕⊝⊝ low^2,3
	0 per 1000	0 per 1000 (0 to 0)
Significant maternal morbidity one or more of the following: significant postpartum haemorrhage requiring blood transfusion; maternal admission to intensive care unit; uterine rupture; hysterectomy	Study population		RR 0.92 (0.38 to 2.22)	459 (1 study)	⊕⊕⊝⊝ low^2,3
	43 per 1000	40 per 1000 (16 to 96)
Admission to NICU	Study population		RR 0.88 (0.35 to 2.23)	545 (3 studies)	⊕⊝⊝⊝ very low^2,3,4
	33 per 1000	29 per 1000 (11 to 73)
	Moderate
	26 per 1000	23 per 1000 (9 to 58)
Caesarean section	Study population		RR 1.02 (0.65 to 1.59)	546 (3 studies)	⊕⊕⊝⊝ low^5,6
	124 per 1000	126 per 1000 (80 to 197)
	Moderate
	154 per 1000	157 per 1000 (100 to 245)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ There were no events for this outcome. ² Few total events (< 30). ³ Wide CI crossing line of no effect and RR > 25%. ⁴ Although all studies address outcome of NICU admission, 2 studies included additional outcome of intermediate nursery admission. Overall this may have compromised the total number of events comparatively. ⁵ One study did not give outcomes for elective C/S, only emergency C/S assessed. ⁶ Two out of three studies had wide CIs crossing the line of no effect. CBCL: child behaviour checklist NICU: neonatal intensive care unit

Summary of findings for the main comparison. Planned early delivery compared with expectant management for improving outcomes of the term suspected compromised baby

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Comparison 1. Planned early delivery versus expectant management

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perinatal mortality Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

2 Major neonatal morbidity Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.01, 2.81]

3 Neurodevelopmental disability/impairment Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	2.04 [0.62, 6.69]

4 Maternal mortality Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	3.07 [0.13, 74.87]

5 Major maternal morbidity Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.38, 2.22]

6 Neonatal seizures Show forest plot	1	336	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

7 Necrotising enterocolitis Show forest plot	1	333	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

8 Respiratory distress syndrome Show forest plot	1	333	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.98]

9 Meconium aspiration Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.32]

10 Gestational age at birth (days) Show forest plot	1	459	Mean Difference (IV, Fixed, 95% CI)	‐9.5 [‐10.82, ‐8.18]

11 Gestational age ≥ 40 weeks (not pre‐specified) Show forest plot	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.10 [0.01, 0.67]

12 Apgar score < 7 at 5 minutes Show forest plot	3	546	Risk Ratio (M‐H, Fixed, 95% CI)	2.56 [0.50, 13.04]

13 Resuscitation required Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 2.10]

14 Requirement for mechanical ventilation Show forest plot	1	337	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.01, 4.11]

15 Birthweight < 10 centile Show forest plot	2	491	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.88, 1.10]

16 Birthweight < 2.3 centile (not pre‐specified) Show forest plot	2	491	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.36, 0.73]

17 Admission to NICU Show forest plot	3	545	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.35, 2.23]

18 Admission to intermediate care nursery (not pre‐specified) Show forest plot	2	491	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [1.02, 1.61]

19 Length of stay in NICU/SCN (days) Show forest plot	1	459	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐1.28, 1.28]

20 Interval (days) between randomisation and delivery Show forest plot	1	459	Mean Difference (IV, Fixed, 95% CI)	‐8.68 [‐10.04, ‐7.32]

21 Neonatal sepsis Show forest plot	2	366	Risk Ratio (M‐H, Fixed, 95% CI)	3.18 [0.14, 72.75]

22 Caesarean section Show forest plot	3	546	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.65, 1.59]

23 Placental abruption Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	3.07 [0.13, 74.87]

24 Pre‐eclampsia Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.27, 1.49]

25 Induction of labour Show forest plot	1	459	Risk Ratio (M‐H, Fixed, 95% CI)	2.05 [1.78, 2.37]

26 Vaginal birth Show forest plot	3	546	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.90, 1.07]

27 Assisted vaginal birth Show forest plot	3	546	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.69, 2.04]

28 Breastfeeding Show forest plot	1	218	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.85, 1.40]

29 Breastfeeding (weeks) Show forest plot	1	124	Mean Difference (IV, Fixed, 95% CI)	1.74 [‐3.37, 6.85]

30 Maternal hospital stay (days) (not pre‐specified) Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	1.0 [0.68, 1.32]

Comparison 1. Planned early delivery versus expectant management

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