External cephalic version for breech presentation before term

Eileen K Hutton; G Justus Hofmeyr; Therese Dowswell

doi:10.1002/14651858.CD000084.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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Analysis 1.1

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 1 Non‐cephalic presentation at the birth.

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Analysis 1.2

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 2 Vaginal cephalic birth not achieved (CS + breech vaginal birth).

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Analysis 1.3

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 3 Caesarean section.

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Analysis 1.4

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 4 Vaginal breech birth.

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Analysis 1.5

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 5 Apgar score < 7 at 1 minute.

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Analysis 1.6

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 6 Perinatal mortality.

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Analysis 2.1

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 1 Non‐cephalic presentation at the birth.

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Analysis 2.2

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 2 Vaginal cephalic birth not achieved (CS + breech vaginal birth).

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Analysis 2.3

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 3 Caesarean section.

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Analysis 2.4

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 4 Vaginal breech birth.

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Analysis 2.5

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 5 Apgar score < 7 at 5 minutes.

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Analysis 2.6

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 6 Stillbirth and neonatal mortality < 7 days.

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Analysis 3.1

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 1 Non‐cephalic presentation at the birth.

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Analysis 3.2

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 2 Vaginal cephalic birth not achieved (CS + vaginal breech birth).

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Analysis 3.3

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 3 Caesarean section.

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Analysis 3.4

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 4 Vaginal breech birth.

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Analysis 3.5

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 5 Apgar score < 7 at 5 minutes.

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Analysis 3.6

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 6 Stillbirth or neonatal mortality < 7 days.

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Analysis 3.7

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 7 Preterm birth < 37 weeks.

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Analysis 3.8

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 8 One or more serious fetal complications following randomisation.

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Analysis 3.9

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 9 NICU stay 4 days or longer.

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Analysis 3.10

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 10 (Non‐prespecified outcome) Maternal pain score (0‐100; 0 = no pain).

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Summary of findings for the main comparison. External cephalic version (ECV) commenced before term versus ECV at term for breech presentation before term

External cephalic version (ECV) commenced before term versus ECV at term for breech presentation before term
Population: women with breech presentation before term Settings: 3 trials, 2 multicentre and 1 in Pakistan Intervention: external cephalic version (ECV) commenced before term Comparison: external cephalic version at term
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	External cephalic version at term	External cephalic version (ECV) commenced before term
Non‐cephalic presentation at the birth	Study population		RR 0.81 (0.74 to 0.9)	1906 (3 studies)	⊕⊕⊕⊕ high
	523 per 1000	424 per 1000 (387 to 471)
	Moderate
	517 per 1000	419 per 1000 (383 to 465)
Vaginal cephalic birth not achieved (caesarean section + vaginal breech birth)	Study population		RR 0.9 (0.83 to 0.97)	1888 (3 studies)	⊕⊕⊕⊕ high
	600 per 1000	540 per 1000 (498 to 582)
	Moderate
	633 per 1000	570 per 1000 (525 to 614)
Caesarean section	Study population		RR 0.92 (0.85 to 1)	1888 (3 studies)	⊕⊕⊕⊕ high
	565 per 1000	519 per 1000 (480 to 565)
	Moderate
	560 per 1000	515 per 1000 (476 to 560)
Vaginal breech birth	Study population		RR 0.44 (0.25 to 0.78)	1888 (3 studies)	⊕⊕⊕⊕ high
	35 per 1000	15 per 1000 (9 to 27)
	Moderate
	26 per 1000	11 per 1000 (6 to 20)
Apgar score < 7 at 5 minutes	Study population		RR 1.16 (0.39 to 3.44)	1759 (2 studies)	⊕⊕⊝⊝ low¹
	7 per 1000	8 per 1000 (3 to 23)
	Moderate
	11 per 1000	13 per 1000 (4 to 38)
Perinatal mortality (Stillbirth or neonatal mortality < 7 days)	Study population		RR 0.23 (0.04 to 1.34)	1887 (3 studies)	⊕⊕⊝⊝ low¹
	5 per 1000	1 per 1000 (0 to 7)
	Moderate
	9 per 1000	2 per 1000 (0 to 12)
Preterm birth < 37 weeks	Study population		RR 1.51 (1.03 to 2.21)	1888 (3 studies)	⊕⊕⊕⊕ high
	43 per 1000	66 per 1000 (45 to 96)
	Moderate
	44 per 1000	66 per 1000 (45 to 97)
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 Wide 95% CI crossing the line of no effect and low event rate.

Summary of findings for the main comparison. External cephalic version (ECV) commenced before term versus ECV at term for breech presentation before term

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Comparison 1. External cephalic version (ECV) before term versus no ECV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cephalic presentation at the birth Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.64, 1.69]

2 Vaginal cephalic birth not achieved (CS + breech vaginal birth) Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.67, 1.62]

3 Caesarean section Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	1.82 [0.57, 5.84]

4 Vaginal breech birth Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.49, 1.52]

5 Apgar score < 7 at 1 minute Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.25, 1.59]

6 Perinatal mortality Show forest plot	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.04, 3.22]

Comparison 1. External cephalic version (ECV) before term versus no ECV

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Comparison 2. External cephalic version (ECV) commenced before term versus no ECV

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cephalic presentation at the birth Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.45, 0.77]

2 Vaginal cephalic birth not achieved (CS + breech vaginal birth) Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.49, 0.80]

3 Caesarean section Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.27, 1.43]

4 Vaginal breech birth Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.46, 0.85]

5 Apgar score < 7 at 5 minutes Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	3.03 [0.13, 73.48]

6 Stillbirth and neonatal mortality < 7 days Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.16]

Comparison 2. External cephalic version (ECV) commenced before term versus no ECV

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Comparison 3. External cephalic version (ECV) commenced before term versus ECV at term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐cephalic presentation at the birth Show forest plot	3	1906	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.74, 0.90]

2 Vaginal cephalic birth not achieved (CS + vaginal breech birth) Show forest plot	3	1888	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.83, 0.97]

3 Caesarean section Show forest plot	3	1888	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.85, 1.00]

4 Vaginal breech birth Show forest plot	3	1888	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.25, 0.78]

5 Apgar score < 7 at 5 minutes Show forest plot	2	1759	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.39, 3.44]

6 Stillbirth or neonatal mortality < 7 days Show forest plot	3	1887	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.04, 1.34]

7 Preterm birth < 37 weeks Show forest plot	3	1888	Risk Ratio (M‐H, Fixed, 95% CI)	1.51 [1.03, 2.21]

8 One or more serious fetal complications following randomisation Show forest plot	2	1761	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.42, 1.79]

9 NICU stay 4 days or longer Show forest plot	1	232	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.49, 12.63]

10 (Non‐prespecified outcome) Maternal pain score (0‐100; 0 = no pain) Show forest plot	1	1533	Mean Difference (IV, Fixed, 95% CI)	‐4.60 [‐7.74, ‐1.46]

Comparison 3. External cephalic version (ECV) commenced before term versus ECV at term

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