Fundal pressure during the second stage of labour

G Justus Hofmeyr; Joshua P Vogel; Anna Cuthbert; Mandisa Singata

doi:10.1002/14651858.CD006067.pub3

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Figure 1

Study flow diagram

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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

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

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Analysis 1.1

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 1 No spontaneous vaginal birth within a specified time, as defined by the trial authors.

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Analysis 1.2

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 2 Instrumental birth.

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Analysis 1.3

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 3 Caesarean section.

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Analysis 1.4

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 4 Operative birth ‐ instrumental or caesarean.

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Analysis 1.5

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 5 Low arterial cord pH.

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Analysis 1.6

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 6 Apgar score less than 7 at 5 minutes.

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Analysis 1.7

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 7 Duration of active second stage.

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Analysis 1.8

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 8 Episiotomy.

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Analysis 1.9

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 9 Soft tissue damage ‐ perineal.

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Analysis 1.10

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 10 Soft tissue damage ‐ vaginal laceration.

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Analysis 1.11

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 11 Soft tissue damage ‐ cervical.

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Analysis 1.12

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 12 Postpartum haemorrhage.

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Analysis 1.13

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 13 Pain after enrolment as defined by trial authors.

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$Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 14 Neonatal trauma ‐ fractures.$

Analysis 1.14

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 14 Neonatal trauma ‐ fractures.

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Analysis 1.15

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 15 Neonatal trauma ‐ haematoma.

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Analysis 1.16

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 16 Admission to neonatal intensive care unit.

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Analysis 1.17

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 17 Neonatal death.

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Analysis 1.18

Comparison 1 Manual fundal pressure versus no fundal pressure, Outcome 18 Sensitivity analysis: low arterial cord pH.

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Analysis 2.1

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 1 Instrumental birth.

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Analysis 2.2

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 2 Caesarean section.

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Analysis 2.3

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 3 Operative birth ‐ instrumental or caesarean section.

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Analysis 2.4

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 4 Low arterial cord pH.

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Analysis 2.5

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 5 Apgar score less than 7 after 5 minutes.

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Analysis 2.6

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 6 Duration of second stage.

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Analysis 2.7

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 7 Episiotomy.

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Analysis 2.8

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 8 Soft tissue damage ‐ perineal.

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Analysis 2.9

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 9 Soft tissue damage ‐ vaginal.

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Analysis 2.10

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 10 Soft tissue damage ‐ anal sphincter.

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Analysis 2.11

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 11 Soft tissue damage ‐ cervical/uterine.

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Analysis 2.12

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 12 Postpartum haemorrhage.

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Analysis 2.13

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 13 Neonatal trauma ‐ haematoma.

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Analysis 2.14

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 14 Admission to neonatal intensive care unit.

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Analysis 2.15

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 15 Sensitivity analysis: instrumental birth.

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Analysis 2.16

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 16 Sensitivity analysis: caesarean section.

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Analysis 2.17

Comparison 2 Fundal pressure by inflatable belt versus no fundal pressure, Outcome 17 Sensitivity analysis: operative delivery ‐ instrumental or caesarean section.

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Summary of findings for the main comparison. Manual fundal pressure compared to no fundal pressure for the second stage of labour

Manual fundal pressure compared to no fundal pressure for the second stage of labour
Patient or population: women with singleton pregnancy in vertex position in second stage of labour Setting: Iran, India, South Africa and Turkey Intervention: manual fundal pressure Comparison: no fundal pressure
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no fundal pressure	Risk with manual fundal pressure
No spontaneous vaginal birth within a specified time, as defined by the trial authors	Study population		RR 0.96 (0.71 to 1.28)	120 (1 RCT)	⊕⊝⊝⊝ Very low^1,2	Reported as "Time from bearing down to birth of head =/>30 min or operative delivery". Data may contain instrumental births and should be interpreted with due caution
	613 per 1000	588 per 1000 (435 to 785)
Operative birth ‐ Instrumental or caesarean birth	Study population		Average RR 0.66 (0.12 to 3.55)	317 (2 RCTs)	⊕⊝⊝⊝ Very low^2,3,4
	61 per 1000	33 per 1000 (12 to 92)
Low arterial cord pH	Study population		RR 1.07 (0.72 to 1.58)	297 (2 RCTs)	⊕⊝⊝⊝ Very low^1,5
	172 per 1000	184 per 1000 (124 to 272)
APGAR score less than 7 at 5 minutes	Study population		Average RR 4.48 (0.28 to 71.45)	2759 (4 RCTs)	⊕⊝⊝⊝ Very low^6,7,8
	5 per 1000	23 per 1000 (1 to 375)
Duration of active second stage	No absolute effects Mean duration of labour 16.6 minutes	No absolute effects Mean duration of labour 17.4 minutes	The mean duration of second stage was 0.8 minutes shorter in the fundal pressure group (3.66 minutes shorter to 2.06 minutes longer)	194 (1 RCT)	⊕⊝⊝⊝ Very low^1,2
Severe maternal morbidity or death	Study population		‐	(0 study)	‐	No trial reported this outcome
	See comment	See comment
Neonatal death	Study population		‐	2445 (2 RCTs)	⊕⊝⊝⊝ Very low^9,10	Zero neonatal deaths reported in both trials
	See comment	See comment
*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
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
¹ Wide confidence interval crossing the line of no effect, few events and small sample size (‐2). ² One study with design limitations (‐1). ³ Studies show inconsistent effects suggesting the two trials may not have measured the same outcome. Therefore not pooled (‐2). ⁴ Very small number of events and sample size (‐2). ⁵ One study with serious design limitations. Large loss to follow‐up for this outcome (‐2). ⁶ Two studies contributing data had design limitations, with more than 40% of weight from a study with serious design limitations (‐2). ⁷ One study contributing data compared Gentle Assisted Pushing, the other compared manual fundal pressure (‐1). ⁸ Wide confidence interval crossing line of no effect (‐1). ⁹ One study with serious design limitations. (‐2). ¹⁰ No events and sample size below 3000 (‐2).

Summary of findings for the main comparison. Manual fundal pressure compared to no fundal pressure for the second stage of labour

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Summary of findings 2. Fundal pressure by inflatable belt compared to no fundal pressure for second stage of labour

Fundal pressure by inflatable belt compared to no fundal pressure for second stage of labour
Patient or population: women with singleton pregnancy in vertex position in second stage of labour Setting: Italy, South Korea and UK Intervention: fundal pressure by inflatable belt Comparison: no fundal pressure
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no fundal pressure	Risk with fundal pressure by inflatable belt
No spontaneous vaginal birth within a specified time	Study population		‐	(0 study)	‐	No trial reported this outcome
	See comment	See comment
Operative birth ‐ instrumental or caesarean section	Study population		Average RR 0.62 (0.38 to 1.01)	891 (4 RCTs)	⊕⊝⊝⊝ Very low^1,2,3
	516 per 1000	320 per 1000 (196 to 521)
Low arterial cord pH	Study population		RR 0.47 (0.09 to 2.55)	461 (1 RCT)	⊕⊕⊝⊝ Low⁴
	18 per 1000	8 per 1000 (2 to 46)
Apgar score less than 7 after 5 minutes	Study population		RR 4.62 (0.22 to 95.68)	500 (1 RCT)	⊕⊝⊝⊝ Very low^4,5
	0 per 1000	0 per 1000 (0 to 0)
Duration of second stage (minutes)	No absolute effects	No absolute effects	The average mean duration of second stage was 50.8 minutes shorter in the inflatable belt group (94.85 minutes shorter to 6.74 minutes shorter)	253 (2 RCTs)	⊕⊝⊝⊝ Very low^4,6,7	Acanfora 2013: mean duration of second stage was 73.47 minutes shorter for women in the inflatable belt group (86.40 minutes shorter to 60.54 minutes shorter) Kim 2013: mean duration of second stage was 28.51 minutes shorter for women in the inflatable belt group (38.50 minutes shorter to 18.52 minutes shorter)
Severe maternal morbidity and death	Study population		‐	(0 study)	‐	No trial reported these outcomes
	See comment	See comment
Neonatal death	Study population		‐	(0 study)	‐	No trial reported this outcome
	See comment	See comment
*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
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
¹ Most studies contributing data had design limitations (‐1). ² Statistical heterogeneity (I² > 60%). Direction of effect consistent but size of effect variable (‐1). ³ Wide confidence interval crossing the line of no effect and estimate based on small sample size (‐2). ⁴ Wide confidence interval crossing the line of no effect, few events and small sample size (‐2). ⁵ One study with design limitations (‐1). ⁶ Most studies contributing data had design limitations, with more than 40% of weight from a study with substantial design limitations (‐2). ⁷ Direction of effect consistent but considerable differences in size of effect (‐2).

Summary of findings 2. Fundal pressure by inflatable belt compared to no fundal pressure for second stage of labour

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Comparison 1. Manual fundal pressure versus no fundal pressure

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 No spontaneous vaginal birth within a specified time, as defined by the trial authors Show forest plot	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.71, 1.28]

2 Instrumental birth Show forest plot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	3.28 [0.14, 79.65]

3 Caesarean section Show forest plot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.07, 17.27]

4 Operative birth ‐ instrumental or caesarean Show forest plot	2	317	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.12, 3.55]

5 Low arterial cord pH Show forest plot	2	297	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.72, 1.58]

6 Apgar score less than 7 at 5 minutes Show forest plot	4	2759	Risk Ratio (M‐H, Random, 95% CI)	4.48 [0.28, 71.45]

7 Duration of active second stage Show forest plot	1	194	Mean Difference (IV, Fixed, 95% CI)	‐0.80 [‐3.66, 2.06]

8 Episiotomy Show forest plot	2	317	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.92, 1.50]

9 Soft tissue damage ‐ perineal Show forest plot	1	209	Risk Ratio (M‐H, Fixed, 95% CI)	6.42 [0.79, 52.37]

10 Soft tissue damage ‐ vaginal laceration Show forest plot	1	295	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.75, 2.03]

11 Soft tissue damage ‐ cervical Show forest plot	1	295	Risk Ratio (M‐H, Fixed, 95% CI)	4.90 [1.09, 21.98]

12 Postpartum haemorrhage Show forest plot	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	1.87 [0.58, 6.06]

13 Pain after enrolment as defined by trial authors Show forest plot	1	209	Risk Ratio (M‐H, Fixed, 95% CI)	4.54 [2.21, 9.34]

14 Neonatal trauma ‐ fractures Show forest plot	1	209	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

15 Neonatal trauma ‐ haematoma Show forest plot	1	209	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

16 Admission to neonatal intensive care unit Show forest plot	1	295	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [0.40, 6.71]

17 Neonatal death Show forest plot	2	2445	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

18 Sensitivity analysis: low arterial cord pH Show forest plot	1	118	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.72, 1.58]

Comparison 1. Manual fundal pressure versus no fundal pressure

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Comparison 2. Fundal pressure by inflatable belt versus no fundal pressure

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Instrumental birth Show forest plot	4	891	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.52, 1.02]

2 Caesarean section Show forest plot	4	891	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.14, 2.26]

3 Operative birth ‐ instrumental or caesarean section Show forest plot	4	891	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.38, 1.01]

4 Low arterial cord pH Show forest plot	1	461	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.09, 2.55]

5 Apgar score less than 7 after 5 minutes Show forest plot	1	500	Risk Ratio (M‐H, Fixed, 95% CI)	4.62 [0.22, 95.68]

6 Duration of second stage Show forest plot	2	253	Mean Difference (IV, Random, 95% CI)	‐50.80 [‐94.85, ‐6.74]

7 Episiotomy Show forest plot	3	811	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.86, 1.12]

8 Soft tissue damage ‐ perineal Show forest plot	4	897	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.20, 1.38]

9 Soft tissue damage ‐ vaginal Show forest plot	1	123	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.27, 2.00]

10 Soft tissue damage ‐ anal sphincter Show forest plot	1	500	Risk Ratio (M‐H, Fixed, 95% CI)	15.69 [2.10, 117.02]

11 Soft tissue damage ‐ cervical/uterine Show forest plot	2	203	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.06, 2.82]

12 Postpartum haemorrhage Show forest plot	1	500	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.09, 1.29]

13 Neonatal trauma ‐ haematoma Show forest plot	1	123	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.90]

14 Admission to neonatal intensive care unit Show forest plot	4	891	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.19, 2.14]

15 Sensitivity analysis: instrumental birth Show forest plot	3	811	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.63, 1.04]

16 Sensitivity analysis: caesarean section Show forest plot	3	811	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.20, 3.19]

17 Sensitivity analysis: operative delivery ‐ instrumental or caesarean section Show forest plot	3	811	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.52, 1.13]

Comparison 2. Fundal pressure by inflatable belt versus no fundal pressure

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