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Versión cefálica externa para la presentación podálida a término

Appendices

Appendix 1. Additional searching carried out in previous version of the review

For Hutton 2006, authors conducted a additional literature search which included electronic databases: The Cochrane Central Register of Controlled Trials (The Cochrane Library, 2005, Issue 1, MEDLINE (1965 to April 2005), EMBASE (1988 to April 2005) and Controlled Clinical Trials randomised controlled trials registry (April 2005), using the search terms: 'external cephalic version or ECV'.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 1

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

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

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

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 1 Non‐cephalic presentation at the birth.
Figures and Tables -
Analysis 1.1

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

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

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 3 Caesarean section.
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Analysis 1.3

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

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 4 Vaginal breech birth.
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Analysis 1.4

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

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 5 Apgar score < 7 at 1 minute.
Figures and Tables -
Analysis 1.5

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

Comparison 1 External cephalic version (ECV) before term versus no ECV, Outcome 6 Perinatal mortality.
Figures and Tables -
Analysis 1.6

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

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 1 Non‐cephalic presentation at the birth.
Figures and Tables -
Analysis 2.1

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

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 2.2

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

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 3 Caesarean section.
Figures and Tables -
Analysis 2.3

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

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 4 Vaginal breech birth.
Figures and Tables -
Analysis 2.4

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

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 5 Apgar score < 7 at 5 minutes.
Figures and Tables -
Analysis 2.5

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

Comparison 2 External cephalic version (ECV) commenced before term versus no ECV, Outcome 6 Stillbirth and neonatal mortality < 7 days.
Figures and Tables -
Analysis 2.6

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

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 1 Non‐cephalic presentation at the birth.
Figures and Tables -
Analysis 3.1

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

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

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 3 Caesarean section.
Figures and Tables -
Analysis 3.3

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

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 4 Vaginal breech birth.
Figures and Tables -
Analysis 3.4

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

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 5 Apgar score < 7 at 5 minutes.
Figures and Tables -
Analysis 3.5

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

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 6 Stillbirth or neonatal mortality < 7 days.
Figures and Tables -
Analysis 3.6

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

Comparison 3 External cephalic version (ECV) commenced before term versus ECV at term, Outcome 7 Preterm birth < 37 weeks.
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Analysis 3.7

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

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 3.8

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

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 3.9

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

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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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).

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.

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

Figures and Tables -
Comparison 1. External cephalic version (ECV) before term versus no ECV
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]

Figures and Tables -
Comparison 2. External cephalic version (ECV) commenced before term versus no ECV
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]

Figures and Tables -
Comparison 3. External cephalic version (ECV) commenced before term versus ECV at term