WHO/RHR/ WHO recommendations for augmentation of labour: Evidence base

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1 WHO/RHR/4.5 WHO recommendations for augmentation of labour: Evidence base

2

3 WHO recommendations for augmentation of labour Evidence base

4 WHO/RHR/4.5 World Health Organization 04 All rights reserved. Publications of the World Health Organization are available on the WHO website ( or can be purchased from WHO Press, World Health Organization, 0 Avenue Appia, Geneva 7, Switzerland (tel.: ; fax: ; Requests for permission to reproduce or translate WHO publications whether for sale or for non-commercial distribution should be addressed to WHO Press through the WHO website ( The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

5 Table of contents Standard criteria for grading of evidence... Box. Standard criteria for grading of evidence... GRADE Tables... 4 Table a. Partograph for monitoring the progress of labour (maternal outcomes)... 4 Table b. Partograph for monitoring the progress of labour (infant outcomes)... 7 Table c. Partograph for monitoring the progress of labour (maternal outcomes)... 8 Table d. Partograph for monitoring the progress of labour (infant outcomes)... 0 Table e. Partograph for monitoring the progress of labour (maternal outcomes)... Table f. Partograph for monitoring the progress of labour (infant outcomes)... 3 Table g. Partograph for monitoring the progress of labour (maternal outcomes)... 4 Table h. Partograph for monitoring the progress of labour (infant outcomes)... 6 Table i. Partograph for monitoring the progress of labour (maternal outcomes)... 7 Table j. Partograph for monitoring the progress of labour (infant outcomes)... 8 Table k. Partograph for monitoring the progress of labour (maternal outcomes)... 9 Table l. Partograph for monitoring the progress of labour (infant outcomes)... Table m. Partograph for monitoring the progress of labour (maternal outcomes)... Table n. Partograph for monitoring the progress of labour (infant outcomes)... 3 Table a. Routine vaginal examination for assessing the progress of labour (maternal outcomes)... 4 Table b. Routine vaginal examination for assessing the progress of labour (infant outcomes)... 5 Table c. Routine vaginal examination for assessing the progress of labour (maternal outcomes)... 6 Table 3a. Package of care for active management of labour for prevention of delay in the first stage of labour (maternal outcomes)... 7 Table 3b. Package of care for active management of labour for prevention of delay in the first stage of labour (infant outcomes)... 9 Table 4a. Early amniotomy and early oxytocin for prevention of delay in the first stage of labour (maternal outcomes) Table 4b. Early amniotomy and early oxytocin for prevention of delay in the first stage of labour (infant outcomes)... 3 Table 4c. Early amniotomy and early oxytocin for prevention of delay in the first stage of labour (maternal and infant outcomes) Table 5a. Oxytocin for prevention of delay in labour in women under epidural analgesia (maternal outcomes) Table 5b. Oxytocin for prevention of delay in labour in women under epidural analgesia (infant outcomes) Table 6a. The use of routine amniotomy (alone) for prevention of delay in the first stage of labour (maternal outcomes) Table 6b. The use of routine amniotomy (alone) for prevention of delay in the first stage of labour (infant outcomes) Table 7a. Antispasmodics for prevention of delay in labour (maternal outcomes)... 5

6 Table 7b. Antispasmodics for prevention of delay in labour (infant outcomes) Table 8a. Effect of pain relief on duration of labour and oxytocin augmentation Table 8b. Effect of pain relief on duration of labour and oxytocin augmentation Table 8c. Effect of pain relief on duration of labour and oxytocin augmentation... 6 Table 8d. Effect of pain relief on duration of labour and oxytocin augmentation... 6 Table 8e. Effect of pain relief on duration of labour and oxytocin augmentation Table 8f. Effect of pain relief on duration of labour and oxytocin augmentation Table 8g. Effect of pain relief on duration of labour and oxytocin augmentation Table 8h. Effect of pain relief on duration of labour and oxytocin augmentation Table 8i. Effect of pain relief on duration of labour and oxytocin augmentation Table 8j. Effect of pain relief on duration of labour and oxytocin augmentation Table 8k. Effect of pain relief on duration of labour and oxytocin augmentation Table 8l. Effect of pain relief on duration of labour and oxytocin augmentation... 7 Table 8m. Effect of pain relief on duration of labour and oxytocin augmentation... 7 Table 8n. Effect of pain relief on duration of labour and oxytocin augmentation Table 9a. Intravenous fluids for shortening the duration of labour (maternal outcomes) Table 9b. Intravenous fluids for shortening the duration of labour (infant outcomes) Table 9c. Intravenous fluids for shortening the duration of labour (maternal outcomes) Table 9d. Intravenous fluids for shortening the duration of labour (infant outcomes) Table 9e. Intravenous fluids for shortening the duration of labour (maternal outcomes) Table 9f. Intravenous fluids for shortening the duration of labour (infant outcomes) Table 9g. Intravenous fluids for shortening the duration of labour (maternal outcomes) Table 9h. Intravenous fluids for shortening the duration of labour (infant outcomes)... 8 Table 0a. Oral fluid and food intake during labour (maternal outcomes)... 8 Table 0b. Oral fluid and food intake during labour (infant outcomes) Table 0c. Oral fluid and food intake during labour (maternal outcomes) Table 0d. Oral fluid and food intake during labour (infant outcomes) Table 0e. Oral fluid and food intake during labour (maternal outcomes) Table 0f. Oral fluid and food intake during labour (infant outcomes) Table 0g. Oral fluid and food intake during labour (maternal outcomes)... 9 Table 0h. Oral fluid and food intake during labour (infant outcomes) Table a. Maternal position and mobility during the first stage of labour for improving outcomes (maternal outcomes)

7 Table b. Maternal position and mobility during the first stage of labour for improving outcomes (infant outcomes)... Table c. Maternal position and mobility during the first stage of labour for improving outcomes (maternal outcomes)... 3 Table d. Maternal position and mobility during the first stage of labour for improving outcomes (infant outcomes)... 6 Table a. Continuous companionship during labour for improving labour outcomes (maternal outcomes)... 7 Table b. Continuous companionship during labour for improving labour outcomes (infant outcomes)... 9 Table 3a. Routine enema for improving labour outcomes (maternal outcomes)... 0 Table 3b. Routine enema for improving labour outcomes (infant outcomes)... Table 4a. Oxytocin (alone) for treatment of slow progress in the first stage of labour (maternal outcomes)... Table 4b. Oxytocin (alone) for treatment of slow progress in the first stage of labour (infant outcomes)... 3 Table 5a. Early versus delayed use of oxytocin for treatment of slow progress in the first stage of labour (maternal outcomes)... 4 Table 5b. Early versus delayed use of oxytocin for treatment of slow progress in the first stage of labour (infant outcomes)... 7 Table 6a. High versus low oxytocin dosage regimen for labour augmentation (maternal outcomes)... 8 Table 6b. High versus low oxytocin dosage regimen for labour augmentation (infant outcomes)... Table 7a. Oral misoprostol for augmenting labour (maternal outcomes)... Table 7b. Oral misoprostol for augmenting labour (infant outcomes)... 4 Table 7c. Oral misoprostol for augmenting labour (maternal outcomes)... 5 Table 7d. Oral misoprostol for augmenting labour (infant outcomes)... 7 Table 8a. The use of routine amniotomy alone for treatment of delay in the first stage of labour (maternal outcomes)... 8 Table 8b. The use of routine amniotomy alone for treatment of delay in the first stage of labour (infant outcomes) Table 9a. Amniotomy and oxytocin for treatment of delay in the first stage of labour (maternal outcomes)... 3 Table 9b. Amniotomy and oxytocin for treatment of delay in the first stage of labour (infant outcomes) Table 0a. Internal versus external tocodynamometry in augmented labour (maternal outcomes) Table 0b. Internal versus external tocodynamometry in augmented labour (infant outcomes)

8 Standard criteria for grading of evidence Box. Standard criteria for grading of evidence

9 Box. (cont.) Standard criteria for grading of evidence

10 Box. (cont.) Standard criteria for grading of evidence Note: All observational will start as low quality evidence but non-controlled (e.g. case series) will be further downgraded to very low quality. 3

11 GRADE Tables Table a. Partograph for monitoring the progress of labour (maternal outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Partograph ( carried out in high- and low-resource settings) No partograph ( carried out in high- and low-resource settings) Duration of first stage of labour (hours) high-resource setting (better indicated by lower values) serious none MD 0.8 higher (0.06 lower to.66 higher) Caesarean section (overall) very serious 3 serious 4 none 46/804 (8.%) 73/786 (%) RR fewer per 000 (0.4 to.7) (from 67 fewer to 54 more) Caesarean section (overall) low-resource setting very serious 5 none /4 (9.4%) 5/0 (4.8%) RR 0.38 (0.4 to 0.6) 54 fewer per 000 (from 97 fewer to 88 fewer) Caesarean section (overall) high-resource setting serious 4 none 5/580 (.6%) /576 (%) RR.03 (0.8 to.8) 6 more per 000 (from 38 fewer to 59 more) GRADE: Grading of Recommendations Assessment, Development and Evaluation ( 4

12 assessment patients Effect Partograph ( carried out in high- and low-resource settings) No partograph ( carried out in high- and low-resource settings) Duration of second stage of labour (hours) high-resource setting (better indicated by lower values) none MD 0 higher (0. lower to 0. higher) MODERATE Epidural analgesia high-resource setting none 53/580 (9.7%) 5/576 (90.5%) RR.0 (0.98 to.05) 9 more per 000 (from 8 fewer to 45 more) MODERATE Oxytocin augmentation high-resource setting none 43/580 (7.9%) 4/576 (7.5%) RR.0 (0.95 to.) 4 more per 000 (from 36 fewer to 7 more) MODERATE Instrumental vaginal delivery serious 6 none 8/804 (7.%) 4/786 (7.%) RR (0.85 to.7) 0 fewer per 000 (from 4 fewer to 46 more) MODERATE Instrumental vaginal delivery low-resource setting very serious 5 serious 4 none 45/4 (0.%) 36/0 (7.%) RR.7 (0.79 to.74) 9 more per 000 (from 36 fewer to 7 more) Instrumental vaginal delivery high-resource setting none 73/580 (9.8%) 78/576 (30.9%) RR 0.97 (0.8 to.5) 9 fewer per 000 (from 59 fewer to 46 more) MODERATE 5

13 assessment patients Effect Partograph ( carried out in high- and low-resource settings) No partograph ( carried out in high- and low-resource settings) Artificial rupture of membranes performed none 83/580 (48.8%) 84/576 (49.3%) RR 0.99 (0.88 to.) 5 fewer per 000 (from 59 fewer to 54 more) MODERATE One study with design limitations. Wide confidence interval crossing the line of no effect and fails to exclude appreciable benefit for the control group. 3 Most contributing data had design limitations, with more than 40% of weight from with serious design limitations. 4 Wide confidence interval crossing the line of no effect. 5 One study with serious design limitations. 6 Most contributing data had design limitations, but with less than 40% of weight from with serious design limitations. 6

14 Table b. Partograph for monitoring the progress of labour (infant outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Inconsistency Indirectness Imprecision Partograph ( carried out in high- and low-resource settings) No partograph ( carried out in high- and lowresource settings) Apgar score < 7 at 5 minutes very none 7/80 serious (0.9%) 9/786 (.%) RR 0.77 (0.9 to.06) 3 fewer per 000 (from 8 fewer to more) Apgar score < 7 at 5 minutes low-resource setting very serious 3 very none /30 serious (0.4%) /0 (%) RR 0.46 (0.04 to 5) 5 fewer per 000 (from 9 fewer to 38 more) Apgar score < 7 at 5 minutes high-resource setting serious 4 very none 6/580 serious (%) 7/576 (.%) RR 0.85 (0.9 to.5) fewer per 000 (from 9 fewer to 8 more) Admission to special care nursery high-resource setting serious 4 serious 5 none 9/580 (3.3%) 0/576 (3.5%) RR 0.94 (0.5 to.75) fewer per 000 (from 7 fewer to 6 more) Studies contributing data had design limitations. Wide confidence interval crossing the line of no effect and few events. 3 One study with design limitations. 4 One study with serious design limitations. 5 Wide confidence interval crossing the line of no effect. 7

15 Table c. Partograph for monitoring the progress of labour (maternal outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Partograph with -hour action line ( carried out in a high-resource setting) Partograph with 4-hour action line ( carried out in a high-resource setting) Serious maternal morbidity or death very serious none 0/805 0/796 not pooled not pooled Blood loss > 500 ml serious 3 none 40/805 (3.3%) 4/796 (.5%) RR.07 (0.9 to.6) 9 more per 000 (from fewer to 3 more) Caesarean section (fetal distress) serious 3 none 5/805 (.8%) 39/796 (.%) RR.3 (0.86 to.96) 7 more per 000 (from 3 fewer to more) Caesarean section (delay in labour) none 0/805 (6.6%) /796 (6.8%) RR 0.98 (0.77 to.5) fewer per 000 (from 6 fewer to MODERATE 7 more) Epidural use none 599/805 (33.%) 574/796 (3%) RR.04 (0.95 to.4) 3 more per 000 (from 6 fewer to MODERATE 45 more) 8

16 assessment patients Effect Partograph with -hour action line ( carried out in a high-resource setting) Partograph with 4-hour action line ( carried out in a high-resource setting) Oxytocin augmentation none 840/805 (46.5%) 736/796 (4%) RR.4 (.05 to.) 57 more per 000 (from 0 more to MODERATE 90 more) Instrumental vaginal delivery none 360/805 (9.9%) 393/796 (.9%) RR 0.9 (0.8 to.03) 0 fewer per 000 (from 44 MODERATE fewer to 7 more) Caesarean section (overall) serious 3 none 7/805 (9.5%) 6/796 (9%) RR.06 (0.85 to.3) 5 more per 000 (from 3 fewer to 9 more) Studies contributing data had design limitations. No events. 3 Wide confidence interval crossing the line of no effect. 9

17 Table d. Partograph for monitoring the progress of labour (infant outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Inconsistency Indirectness Imprecision Partograph with -hour action line ( carried out in a high-resource setting) Partograph with 4-hour action line ( carried out in a high-resource setting) Serious neonatal morbidity or perinatal death very none 0/805 serious 0/796 not pooled not pooled Apgar score < 7 at 5 minutes serious 3 none 8/805 (.6%) 34/796 (.9%) RR fewer per 000 (0.5 to.35) (from 9 fewer to 7 more) Cord ph < 7. serious 3 none 5/805 (.4%) 34/796 (.9%) RR 0.73 (0.44 to.) 5 fewer per 000 (from fewer to 4 more) Admission to special care nursery serious 3 none 5/805 (.4%) 3/796 (.8%) RR 0.78 (0.46 to.3) 4 fewer per 000 (from 0 fewer to 6 more) Studies contributing data had design limitations. No events. 3 Wide confidence interval crossing the line of no effect. 0

18 Table e. Partograph for monitoring the progress of labour (maternal outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Partograph with -hour action line (study carried out in a high-resource setting) Partograph with 3-hour action line (study carried out in a high-resource setting) Serious maternal morbidity or death very serious none 0/35 0/30 not pooled not pooled Blood loss > 500 ml serious 3 none 39/35 (.4%) 39/30 (.9%) RR 0.96 (0.63 to.45) 5 fewer per 000 (from 48 fewer to 58 more) Caesarean section (fetal distress) very serious 4 none /35 (3.8%) /30 (4%) RR 0.96 (0.44 to.) fewer per 000 (from fewer to 44 more) Caesarean section (delay in labour) serious 3 none 3/35 (7.3%) 3/30 (0.3%) RR 0.7 (0.4 to.9) 30 fewer per 000 (from 60 fewer to 0 more) Epidural use serious 3 none 0/35 (38.%) 99/30 (3.8%) RR.6 (0.94 to.44) 5 more per 000 (from 0 fewer to 44 more)

19 assessment patients Effect Partograph with -hour action line (study carried out in a high-resource setting) Partograph with 3-hour action line (study carried out in a high-resource setting) Oxytocin augmentation none 44/35 (45.7%) 36/30 (45%) RR.0 (0.85 to.) 9 more per 000 (from 68 fewer to MODERATE 95 more) Instrumental vaginal delivery serious 3 none 66/35 (%) 68/30 (.5%) RR 0.93 (0.69 to.6) 6 fewer per 000 (from 70 fewer to 59 more) Caesarean section (overall) no methodology chosen none 35/35 (.%) 43/30 (4.%) RR 0.78 (0.5 to.8) 3 fewer per 000 (from 70 fewer to 6 more) One study with design limitations. No events. 3 Wide confidence interval crossing the line of no effect. 4 Wide confidence interval crossing the line of no effect and few events.

20 Table f. Partograph for monitoring the progress of labour (infant outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Inconsistency Indirectness Imprecision Partograph with -hour action line (study carried out in a high-resource setting) Partograph with 3-hour action line (study carried out in a high-resource setting) Serious neonatal morbidity or perinatal death very none 0/35 serious 0/30 not pooled not pooled Apgar score < 7 at 5 minutes very none 6/35 serious 3 (.9%) 4/30 (.3%) RR.44 (0.4 to 5.05) 6 more per 000 (from 8 fewer to 54 more) Cord ph < 7. very none /35 serious 3 (0.6%) 5/30 (.7%) RR 0.38 (0.07 to.96) 0 fewer per 000 (from 5 fewer to 6 more) Admission to special care nursery very none 4/35 serious 3 (.3%) /30 (0.3%) RR 3.83 (0.43 to 34.) 9 more per 000 (from fewer to 0 more) One study with design limitations. No events. 3 Wide confidence interval crossing the line of no effect and few events. 3

21 Table g. Partograph for monitoring the progress of labour (maternal outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Inconsistency Indirectness Imprecision Partograph with 3-hour action line (study carried out in a high-resource setting) Partograph with 4-hour action line (study carried out in a high-resource setting) Serious maternal morbidity or death very none 0/30 serious 0/3 not pooled not pooled Blood loss > 500 ml serious 3 none 39/30 (.9%) 39/3 (.5%) RR.03 (0.68 to.56) 4 more per 000 (from 40 fewer to 70 more) Caesarean section (fetal distress) very none /30 serious 4 (4%) 7/3 (.3%) RR.77 (0.7 to 4.4) 7 more per 000 (from 7 fewer to 77 more) Caesarean section (delay in labour) serious 3 none 3/30 (0.3%) 9/3 (6.%) RR.68 (0.97 to.9) 4 more per 000 (from fewer to 7 more) Epidural use serious 3 none 99/30 (3.8%) 0/3 (3.5%) RR.0 (0.8 to.7) 3 more per 000 (from 65 fewer to 88 more) 4

22 assessment patients Effect Inconsistency Indirectness Imprecision Partograph with 3-hour action line (study carried out in a high-resource setting) Partograph with 4-hour action line (study carried out in a high-resource setting) Oxytocin augmentation serious 3 none 36/30 (45%) 9/3 (4.5%) RR.09 (0.9 to.3) 37 more per 000 (from 37 fewer to 4 more) Instrumental vaginal delivery serious 3 none 68/30 (.5%) 73/3 (3.5%) RR 0.96 (0.7 to.8) 9 fewer per 000 (from 66 fewer to 66 more) Caesarean section (overall) no methodology chosen none 43/30 (4.%) 6/3 (8.4%) RR.7 (.07 to.7) 59 more per 000 (from 6 more to 4 more) One study with design limitations. No events. 3 Wide confidence interval crossing the line of no effect. 4 Wide confidence interval crossing the line of no effect and few events. 5

23 Table h. Partograph for monitoring the progress of labour (infant outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Inconsistency Indirectness Imprecision Partograph with 3-hour action line (study carried out in a high-resource setting) Partograph with 4-hour action line (study carried out in a high-resource setting) Serious neonatal morbidity or perinatal death very none 0/30 serious 0/3 not pooled not pooled Apgar score < 7 at 5 minutes very none 4/30 serious 3 (.3%) 5/3 (.6%) RR 0.8 (0. to 3.04) 3 fewer per 000 (from 3 fewer to 33 more) Cord ph < 7. very none 5/30 serious 3 (.7%) /3 (0.64%) RR.57 (0.5 to 3.7) 0 more per 000 (from 3 fewer to 78 more) Admission to special care nursery very none /30 serious 3 (0.3%) /3 (0.6%) RR 0.5 (0.05 to 5.65) 3 fewer per 000 (from 6 fewer to 30 more) One study with design limitations. No events. 3 Wide confidence interval crossing the line of no effect and few events. 6

24 Table i. Partograph for monitoring the progress of labour (maternal outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Partograph with alert line only (study carried out in a low-resource setting) Partograph with alert line only versus partograph with alert and action line (study carried out in a low-resource setting) Caesarean section (overall) none 55/344 (6%) 8/350 (3.4%) RR 0.68 (0.5 to 0.93) 75 fewer per 000 (from 6 fewer to 7 fewer) MODERATE Oxytocin augmentation serious serious 3 none 77/344 (.4%) 97/350 (7.7%) RR 0.8 (0.6 to.05) 53 fewer per 000 (from 05 fewer to 4 more) Instrumental vaginal delivery serious none 70/344 (0.3%) 8/350 (3.4%) RR 0.87 (0.66 to.5) 30 fewer per 000 (from 80 fewer to 35 more) One study with design limitations. Wide confidence interval crossing the line of no effect. 3 No explanation was provided. 7

25 Table j. Partograph for monitoring the progress of labour (infant outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Inconsistency Indirectness Imprecision Partograph with alert line only (study carried out in a low-resource setting) Partograph with alert line only versus partograph with alert and action line (study carried out in a low-resource setting) Perinatal death very none 3/344 serious (0.9%) 0/350 RR 7. (0.37 to 37.36) - Apgar score < 7 at 5 minutes very none 3/344 serious (0.9%) 0/350 RR 7. (0.37 to 37.36) - One study with design limitations. Wide confidence interval crossing the line of no effect and few events. 8

26 Table k. Partograph for monitoring the progress of labour (maternal outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Earlier intervention (combined analysis for in high- and lowresource settings) Later intervention (combined analysis for in high- and lowresource settings) Caesarean section (overall) all settings 3 randomized serious none 6/49 (0.5%) 43/46 (.3%) RR 0.94 (0.67 to.3) 7 fewer per 000 (from 37 fewer to 35 more) Caesarean section (overall) low-resource setting serious 3 none 55/344 (6%) 8/350 (3.4%) RR 0.68 (0.5 to 0.93) 75 fewer per 000 (from 6 fewer to 7 fewer) MODERATE Caesarean section (overall) high-resource setting serious none 7/805 (9.5%) 6/796 (9%) RR.06 (0.85 to.3) 5 more per 000 (from 3 fewer to 9 more) Instrumental delivery all settings 3 randomized serious none 430/49 (0%) 475/46 (.%) RR 0.9 (0.8 to.0) fewer per 000 (from 44 fewer to 4 more) Instrumental delivery low-resource setting serious 3 serious none 70/344 (0.3%) 8/350 (3.4%) RR 0.87 (0.66 to.5) 30 fewer per 000 (from 80 fewer to 35 more) 9

27 assessment patients Effect Earlier intervention (combined analysis for in high- and lowresource settings) Later intervention (combined analysis for in high- and lowresource settings) Instrumental delivery high-resource setting serious none 360/805 (9.9%) 393/796 (.9%) RR 0.9 (0.8 to.03) 0 fewer per 000 (from 44 fewer to 7 more) Most contributing data had design limitations. Wide confidence interval crossing the line of no effect. 3 One study with design limitations. 0

28 Table l. Partograph for monitoring the progress of labour (infant outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Inconsistency Indirectness Imprecision Earlier intervention (combined analysis for in high- and low-resource settings) Later intervention (combined analysis for in high- and low-resource settings) Apgar score low at 5 or 0 minutes 3 randomized serious none 3/49 (.4%) 34/46 (.6%) RR 0.95 (0.48 to.86) fewer per 000 (from 8 fewer to 4 more) Apgar score low at 5 or 0 minutes low-resource setting serious 3 very none 3/344 serious 4 (0.9%) 0/350 RR 7. (0.37 to 37.36) - Apgar score low at 5 or 0 minutes high-resource setting serious none 8/805 (.6%) 34/796 (.9%) RR fewer per 000 (0.5 to.35) (from 9 fewer to 7 more) Most contributing data had design limitations. Wide confidence interval crossing the line of no effect. 3 One study with design limitations. 4 Wide confidence interval crossing the line of no effect and few events.

29 Table m. Partograph for monitoring the progress of labour (maternal outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Partograph with latent phase Partograph without latent phase Caesarean section (fetal distress) none 65/350 (8.6%) 5/393 (3.8%) RR 4.87 ( more per 000 (from to 8.37) 70 more to 8 more) MODERATE Caesarean section (delay in labour) very serious none /350 (3.4%) 0/393 (.5%) RR.35 (0.59 to 3.08) 9 more per 000 (from 0 fewer to 53 more) Caesarean section (overall) none 83/350 (3.7%) 38/393 (9.7%) RR.45 (.7 40 more per 000 (from to 3.5) 70 more to 4 more) MODERATE Oxytocin augmentation none 6/350 (36%) 65/393 (6.5%) RR.8 ( more per 000 (from to.83) more to 303 more) MODERATE Instrumental vaginal delivery serious 3 none 4/350 (6.9%) 6/393 (6.6%) RR.04 (0.6 to.77) 3 more per 000 (from 6 fewer to 5 more) One study with design limitations. Wide confidence interval crossing the line of no effect and few events. 3 Wide confidence interval crossing the line of no effect.

30 Table n. Partograph for monitoring the progress of labour (infant outcomes) Source: Lavender T, Hart A, Smyth RMD. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Partograph with latent phase Partograph without latent phase Apgar score < 7 at 5 minutes very serious none 4/350 (.%) 6/393 (.5%) RR 0.75 (0. to.63) 4 fewer per 000 (from fewer to 5 more) Admission to special care nursery none 69/350 (9.7%) 4/393 (0.7%) RR.84 (.9 to.63) 90 more per 000 (from 3 more to 74 more) MODERATE One study with design limitations. Wide confidence interval crossing the line of no effect and few events. 3

31 Table a. Routine vaginal examination for assessing the progress of labour (maternal outcomes) Source: Downe S, Gill GML, Dahlen, Dahlen HG, Singata M. Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Vaginal examination Rectal examination Caesarean section very serious none /54 (0.6%) 3/53 (%) RR 0.33 (0.03 to 3.5) 3 fewer per 000 (from 9 fewer to 4 more) Spontaneous vaginal birth none 35/54 (87.7%) 37/53 (89.5%) RR 0.98 (0.9 to.06) 8 fewer per 000 (from 90 fewer to 54 more) MODERATE Operative vaginal birth serious 3 none 8/54 (.7%) 3/53 (8.5%) RR.38 (0.7 to.7) 3 more per 000 (from 5 fewer to 45 more) Augmentation of labour serious 3 none 7/54 (7.5%) 6/53 (7%) RR.03 (0.63 to.68) 5 more per 000 (from 63 fewer to 6 more) Maternal infection with unknown treatment (not pre-specified) very serious none 8/54 (5.%) 6/53 (0.5%) RR 0.5 (0. to.3) 5 fewer per 000 (from 8 fewer to 4 more) Very uncomfortable (not pre-specified) none 7/5 (.3%) 4/5 (7%) RR 0.4 (0.5 to 0.7) 56 fewer per 000 (from 8 fewer to 0 fewer) MODERATE One trial with design limitations. Wide confidence interval crossing the line of no effect and few events. 3 Wide confidence interval crossing the line of no effect. 4

32 Table b. Routine vaginal examination for assessing the progress of labour (infant outcomes) Source: Downe S, Gill GML, Dahlen, Dahlen HG, Singata M. Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Vaginal examination Rectal examination Perinatal mortality very none /54 serious (0.6%) /53 (0.7%) RR 0.99 (0.06 to 5.74) 0 fewer per 000 (from 6 fewer to 96 more) Neonatal infection requiring antibiotics (primary outcome) very none 0/54 serious /53 (0.7%) RR 0.33 (0.0 to 8.07) 4 fewer per 000 (from 6 fewer to 46 more) Admission to neonatal intensive care unit very none 8/54 serious (5.%) 6/53 (3.9%) RR.3 (0.47 to 3.73) 3 more per 000 (from fewer to 07 more) Infant infection with unknown treatment (not pre-specified) very none /54 serious (.3%) /53 (.3%) RR 0.99 (0.4 to 6.96) 0 fewer per 000 (from fewer to 78 more) One trial with design limitations. Wide confidence interval crossing the line of no effect and few events. 5

33 Table c. Routine vaginal examination for assessing the progress of labour (maternal outcomes) Source: Downe S, Gill GML, Dahlen, Dahlen HG, Singata M. Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term. Cochrane Database Syst Rev. 03;(7):CD assessment patients Effect Vaginal examinations hourly Vaginal examinations 4 hourly Duration of labour (minutes) (primary outcome) (better indicated by lower values) very very serious none MD 6 lower (88.7 lower to 76.7 higher) Caesarean section serious 3 very serious none 0/75 (3.3%) 3/75 (7.3%) RR fewer per 000 (from (0.36 to.64) fewer to more) Spontaneous vaginal birth serious 3 none 5/75 (69.3%) 53/75 (70.7%) RR 0.98 (0.8 to.) 4 fewer per 000 (from 4 fewer to 48 more) MODERATE Epidural for pain relief very very serious none /55 (0%) 4/54 (5.9%) RR fewer per 000 (from (0.39 to.55) 58 fewer to 43 more) Operative vaginal birth serious 3 very serious none 3/75 (7.3%) 9/75 (%) RR more per 000 (from (0.66 to 3.7) 4 fewer to 60 more) Augmentation of labour very very serious none /55 (38.%) 0/54 (37%) RR.03 more per 000 (from (0.64 to.67) 33 fewer to 48 more) One trial with serious design limitations. Wide confidence interval crossing the line of no effect and small sample size. 3 One trial with serious design limitations (ITT data used in this analysis). 6

34 Table 3a. Package of care for active management of labour for prevention of delay in the first stage of labour (maternal outcomes) Source: Brown HC, Paranjothy S, Dowswell T, Thomas J. Package of care for active management in labour for reducing caesarean section rates in low-risk women. Cochrane Database Syst Rev. 008;(4):CD assessment patients Effect Active management of labour Routine care Duration of labour (hours from admission to delivery) (better indicated by lower values) 4 randomized serious none MD.7 lower (.9 to 0.36 lower) Postpartum haemorrhage (blood loss > 500 ml) 3 randomized serious 3 none 57/74 (7.7%) 63/763 (8.3%) RR 0.93 (0.67 to.3) 6 fewer per 000 (from 7 fewer to 6 more) Duration of first stage of labour (hours) (better indicated by lower values) 4 randomized serious 4 none MD.56 lower (.7 to 0.96 lower) Caesarean section rate all women 7 randomized very serious 5 none 343/573 (3.3%) 46/87 (4.8%) RR 0.88 (0.77 to.0) 8 fewer per 000 (from 34 fewer to more) Caesarean section rate all women (Frigoletto [995] study women eligible in labour) 7 randomized none 0/4 (9.8%) 307/496 (.3%) RR 0.8 (0.69 to 0.97) fewer per 000 (from 4 fewer to 38 fewer) MODERATE Caesarean section rate (sensitivity analysis: Frigoletto [995] study excluded) 6 randomized none 46/564 (9.3%) 40/9 (.6%) RR 0.77 (0.63 to 0.94) 9 fewer per 000 (from 8 fewer to 46 fewer) MODERATE 7

35 assessment patients Effect Active management of labour Routine care Duration of second stage (hours) (better indicated by lower values) 5 randomized none MD 0.0 lower (0.06 lower to 0.0 higher) MODERATE Maternal infection (various definitions) 5 randomized serious 6 serious 3 none 3/4 (9.3%) 5/757 (8.7%) RR.4 (0.65 to.98) more per 000 (from 30 fewer to 85 more) Number of women having epidural analgesia 4 randomized none 575/03 (56.%) 553/044 (53%) RR.06 (0.98 to.4) 3 more per 000 (from fewer to 74 more) MODERATE Assisted vaginal delivery rates 6 randomized none 309/564 (9.8%) 360/9 (8.8%) RR 0.99 (0.87 to.4) fewer per 000 (from 4 fewer to 6 more) MODERATE Prolonged labour (> hours) 6 randomized serious 7 none 63/48 (%) 4/76 (3.4%) RR 0.47 (0.3 to 0.69) 4 fewer per 000 (from 73 fewer to 59 fewer) Overall satisfaction with care serious 3 none 90/43 (78.%) 69/5 (75.%) RR.04 (0.94 to.5) 30 more per 000 (from 45 fewer to 3 more) Most contributing data had design limitations. Statistical heterogeneity (I = 9%). Considerable variation in size of effect. 3 Wide confidence interval crossing the line of no effect. 4 Statistical heterogeneity (I = 84%). Considerable variation in size of effect. 5 Most contributing data had design limitations, with more than 40% of weight from a study with serious design limitations. 6 Statistical heterogeneity (I = 80%). Considerable variation in size of effect. 7 Statistical heterogeneity (I = 75%). Considerable variation in size of effect. 8

36 Table 3b. Package of care for active management of labour for prevention of delay in the first stage of labour (infant outcomes) Source: Brown HC, Paranjothy S, Dowswell T, Thomas J. Package of care for active management in labour for reducing caesarean section rates in low-risk women. Cochrane Database Syst Rev. 008;(4):CD assessment patients Effect Active management of labour Routine care Low APGAR score at 5 minutes 5 randomized serious none 47/44 (3.8%) 43/7 (3.4%) RR. (0.76 to.64) 4 more per 000 (from 8 fewer to more) Admission to special care (various definitions) 4 randomized serious none 35/03 (3.4%) 39/044 (3.7%) RR 0.9 (0.59 to.43) 3 fewer per 000 (from 5 fewer to 6 more) Meconium staining 4 randomized serious none 79/03 (7.7%) 00/353 (7.4%) RR 0.93 (0.7 to.4) 5 fewer per 000 (from fewer to 8 more) Most contributing data had design limitations. Wide confidence interval crossing the line of no effect. 9

37 Table 4a. Early amniotomy and early oxytocin for prevention of delay in the first stage of labour (maternal outcomes) Source: Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 03;(8):CD assessment patients Effect Early amniotomy and early oxytocin Routine care Duration of labour (hours from admission in labour) prevention (better indicated by lower values) 7 randomized serious none MD. lower (.8 to 0.4 lower) Postpartum haemorrhage (blood loss > 500 ml) prevention 4 randomized serious 3 none 00/390 (7.%) /84 (8.6%) RR 0.83 (0.65 to.08) 5 fewer per 000 (from 30 fewer to 7 more) Duration of first stage of labour (hours) prevention (better indicated by lower values) 4 randomized serious 4 none MD.57 lower (.5 to lower) Caesarean section rate prevention very none 4/376 (0.9%) 497/399 (.5%) RR 0.87 (0.77 to 0.99) 6 fewer per 000 (from fewer to 9 fewer) Hyperstimulation of labour prevention serious 5 none 4/4 (5.7%) 8/43 (4.%) RR.37 (0.76 to.46) 5 more per 000 (from 0 fewer to 6 more) Spontaneous vaginal birth prevention 9 randomized none 677/703 (6%) 708/3035 (56.3%) RR.0 (0.97 to.05) 6 more per 000 (from 7 fewer to 8 more) MODERATE 30

38 assessment patients Effect Early amniotomy and early oxytocin Routine care Satisfied with labour experience prevention none 0/3 (90.9%) 079/04 (89.6%) RR.0 (0.99 to.04) 8 more per 000 (from 9 fewer to 36 more) MODERATE Postpartum fever or infection prevention 5 randomized serious 3 none 94/44 (7.6%) 39/580 (8.8%) RR 0.88 (0.66 to.6) fewer per 000 (from 30 fewer to 4 more) Maternal blood transfusion prevention 3 randomized serious 6 very serious 5 none /490 (0.8%) 5/487 (0.3%) RR.84 (0.3 to 0.48) 3 more per 000 (from fewer to 3 more) Most of the pooled effect was provided by with design limitations. Statistical heterogeneity (I = 94%). Although the direction of effect was the same, the effect size varied considerably between. 3 Wide confidence interval crossing the line of no effect. 4 Statistical heterogeneity (I > 60%). Direction of effect consistent but size of effect variable. 5 Wide confidence interval crossing the line of no effect and failed to exclude appreciable harm. 6 Statistical heterogeneity (I = 49%). Considerable variation in size and direction of effect. 3

39 Table 4b. Early amniotomy and early oxytocin for prevention of delay in the first stage of labour (infant outcomes) Source: Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 03;(8):CD assessment patients Effect Early amniotomy and early oxytocin Routine care Serious morbidity (seizure/neurological abnormalities) prevention very none 5/336 serious (0.4%) 6/330 (0.5%) RR 0.83 (0.5 to.7) fewer per 000 (from 3 fewer to 8 more) Apgar score < 7 at 5 minutes prevention 6 randomized serious 3 none 57/3 (.6%) 53/48 (.4%) RR. (0.77 to.55) more per 000 (from 5 fewer to 3 more) Acidosis as defined abnormal arterial cord ph (ph < 7.0 or 7.0) prevention 3 randomized serious 3 none /703 (3.%) 0/73 (.8%) RR. (0.6 to.0) 3 more per 000 (from fewer to 9 more) Admission to special care nursery prevention 6 randomized serious 3 none 54/3 (6.9%) 39/48 (6.%) RR.3 (0.9 to.4) 8 more per 000 (from 6 fewer to 5 more) Jaundice or hyperbilirubinemia prevention serious 3 none 34/08 (3.%) 3/ (.8%) RR. (0.68 to.77) 3 more per 000 (from 9 fewer to more) Fetal distress prevention very none 3/54 serious (.4%) /558 (%) RR. (0.55 to.69) 4 more per 000 (from 9 fewer to 33 more) 3

40 assessment patients Effect Early amniotomy and early oxytocin Routine care Suboptimal or abnormal fetal heart tracing prevention very none 3/35 serious (0.9%) 6/354 (.7%) RR 0.5 (0.3 to ) 8 fewer per 000 (from 5 fewer to 7 more) NOT Most contributing data had design limitations. Wide confidence interval crossing the line of no effect, few events and failed to exclude appreciable harm or benefit. 3 Wide confidence interval crossing the line of no effect. 33

41 Table 4c. Early amniotomy and early oxytocin for prevention of delay in the first stage of labour (maternal and infant outcomes) Source: Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 03;(8):CD assessment patients Effect Early amniotomy and early oxytocin (without active management of labour ) Routine care Caesarean section rate 7 randomized serious none 73/8 (7.6%) 5/603 (9.7%) RR 0.84 (0.7 to.0) 5 fewer per 000 (from 9 fewer to more) 4.% 3 fewer per 000 (from 4 fewer to more) Duration of labour (hours from admission in labour) (better indicated by lower values) 5 randomized serious 3 none MD 0.8 lower (.36 to 0.5 lower) Spontaneous vaginal birth 7 randomized none 589/8 (69.6%) 788/603 (68.7%) RR.0 (0.98 to.06) 4 more per 000 (from 4 fewer to 4 more) MODERATE Instrumental vaginal delivery (forceps or vacuum, or both) 7 randomized none 5/8 (.8%) 563/603 (.6%) RR (0.9 to.) 0 fewer per 000 (from fewer to 4 MODERATE more) Duration of first stage of labour (hours) (better indicated by lower values) serious 3 none MD.7 lower (.08 to 0.47 lower) 34

42 assessment patients Effect Early amniotomy and early oxytocin (without active management of labour ) Routine care Use of epidural analgesia 5 randomized none 79/887 (6.5%) 7/888 (59.%) RR.04 (0.98 to.) 4 more per 000 (from fewer to 59 more) MODERATE Postpartum haemorrhage (blood loss > 500 ml) serious none 9/969 (9.4%) 95/85 (.%) RR 0.88 (0.6 to.8) 3 fewer per 000 (from 45 fewer to 3 more) Maternal blood transfusion 3 randomized very serious 4 none /490 (0.8%) 5/487 (0.3%) RR.84 (0.3 to 0.48) 3 more per 000 (from fewer to 3 more) Postpartum fever or infection 3 randomized serious none 4/83 (5.%) 79/48 (6.9%) RR fewer per 000 (0.48 to.58) (from 36 fewer to 40 more) Satisfied with labour experience none 0/3 (90.9%) 079/04 (89.6%) RR.0 (0.99 to.04) 8 more per 000 (from 9 fewer to 35 more) MODERATE Apgar score < 7 at 5 minutes 4 randomized very serious 4 none 7/80 (0.9%) 5/86 (0.8%) RR.3 (0.57 to.) more per 000 (from 4 fewer to 0 more) 35

43 assessment patients Effect Early amniotomy and early oxytocin (without active management of labour ) Routine care Acidosis as defined abnormal arterial cord ph (ph < 7.0 or 7.0) very serious 4 none 0/503 (4%) 8/508 (3.5%) RR. (0.6 to.) 4 more per 000 (from 4 fewer to 39 more) Suboptimal or abnormal fetal heart very serious 4 none 3/35 (0.9%) 6/354 (.7%) RR 0.5 (0.3 to ) 8 fewer per 000 (from 5 fewer to 7 more) Fetal distress very serious 4 none 4/30 (.3%) 4/33 (.%) RR.03 (0.6 to 4.) 0 more per 000 (from 9 fewer to 37 more) Admission to special care nursery 4 randomized serious none 3/80 (6.%) 99/86 (5.5%) RR.5 (0.89 to.5) 8 more per 000 (from 6 fewer to 7 more) Seizure/neurological abnormalities very serious 4 none 5/336 (0.4%) 6/330 (0.5%) RR 0.83 (0.5 to.7) fewer per 000 (from 3 fewer to 8 more) Jaundice or hyperbilirubinemia serious none 34/08 (3.%) 3/ (.8%) RR. (0.68 to.77) 3 more per 000 (from 9 fewer to more) Most contributing data had design limitations. Wide confidence interval crossing the line of no effect. 3 Statistical heterogeneity (I > 70%). Considerable variation in size of effect. 4 Wide confidence interval crossing the line of no effect and few events. 36

44 Table 5a. Oxytocin for prevention of delay in labour in women under epidural analgesia (maternal outcomes) Source: Costley PL, East CE. Oxytocin augmentation of labour in women with epidural analgesia for reducing operative deliveries. Cochrane Database Syst Rev. 03;(7):CD0094. assessment patients Effect Oxytocin Placebo Postpartum haemorrhage risk of none 4/54 (5.6%) 7/65 RR 0.96 (0.58 to (6.4%).59) 7 fewer per 000 (from 69 fewer to 97 more) MODERATE Caesarean section all risk of very none 0/54 serious (6.5%) /65 (6.7%) RR 0.95 (0.4 to.) 3 fewer per 000 (from 39 fewer to 75 more) Caesarean section cervical dilatation < 0 cm risk of very none 8/46 serious (7.4%) 7/47 RR.7 (0.46 to 5 more per 000 (from 80 fewer (4.9%).96) to 9 more) Caesarean section cervical dilatation 0 cm risk of very none /08 serious (.9%) 4/8 (3.4%) RR 0.55 (0. to.9) 5 fewer per 000 (from 3 fewer to 65 more) Uterine hyperstimulation risk of very none 5/08 serious 3 (48.%) 43/8 RR.3 (0.97 to (36.4%).8) 7 more per 000 (from fewer to 9 more) Instrumental deliveries (all) risk of none 78/54 (50.6%) 95/65 RR 0.88 (0.7 to (57.6%).08) 69 fewer per 000 (from 6 fewer to 46 more) MODERATE 37

45 assessment patients Effect Oxytocin Placebo Instrumental deliveries cervical dilatation < 0 cm risk of very none 6/46 serious 3 (56.5%) 8/47 RR 0.95 (0.67 to (59.6%).34) 30 fewer per 000 (from 97 fewer to 03 more) Instrumental deliveries cervical dilatation 0 cm risk of very none 5/08 serious 3 (48.%) 67/8 RR 0.85 (0.66 to (56.8%).09) 85 fewer per 000 (from 93 fewer to 5 more) Combined operative deliveries risk of serious 4 none 88/54 (57.%) 99/65 (60%) RR.0 (0.68 to.5) 6 more per 000 (from 9 fewer to 300 more) Wide confidence interval crossing the line of no effect. Wide confidence interval crossing the line of no effect and few events. 3 Wide confidence interval crossing the line of no effect and small sample size. 4 Statistical heterogeneity (I =77%). Direction of effect different in the two. 38

46 Table 5b. Oxytocin for women under epidural analgesia (infant outcomes) Source: Costley PL, East CE. Oxytocin augmentation of labour in women with epidural analgesia for reducing operative deliveries. Cochrane Database Syst Rev. 03;(7):CD0094. assessment patients Effect Oxytocin Placebo Apgar score < 4 at 5 minutes risk of very none 0/08 0/8 not pooled not pooled Apgar score < 7 at 5 minutes risk of very none /54 serious (0.6%) 0/65 RR 3.06 (0.3 to 73.33) - Admission to neonatal intensive care unit risk of very none 4/54 serious (.6%) 4/65 (.4%) RR.07 (0.9 to 3.93) more per 000 (from 7 fewer to 7 more) No events. Wide confidence interval crossing the line of no effect and few events. 39

47 Table 6a. The use of routine amniotomy (alone) for prevention of delay in the first stage of labour (maternal outcomes) Source: Smyth RMD, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 03;(6):CD assessment patients Effect Amniotomy (normal progression at randomization) No amniotomy Maternal mortality 3 randomized very serious none /87 (0.%) 0/868 RR 3.0 (0. to 73.6) - Postpartum haemorrhage very serious none 4/985 (0.4%) 8/837 (%) RR 0.46 (0.4 to.5) 5 fewer per 000 (from 8 fewer to 5 more) Postpartum haemorrhage primiparous and multiparous women very serious none /645 (0.%) 4/487 (0.8%) RR 0.9 (0.0 to.68) 7 fewer per 000 (from 8 fewer to 6 more) Postpartum haemorrhage primiparous women very serious none /74 (.4%) /83 (.4%) RR 0.56 (0.05 fewer per 000 (from to 6.06) 3 fewer to more) Postpartum haemorrhage multiparous women very serious none /66 (0.8%) /67 (0.7%) RR (0.4 to 7.07) 0 fewer per 000 (from 6 fewer to 45 more) Duration of first stage of labour (minutes) (better indicated by lower values) 5 randomized very serious 3 serious 4 none MD 0.43 lower (95.93 lower to higher) 40

48 assessment patients Effect Amniotomy (normal progression at randomization) No amniotomy Duration of first stage of labour (minutes) primiparous women (better indicated by lower values) 4 randomized very serious 3 serious 5 none MD lower (5.66 lower to 36.8 higher) Duration of first stage of labour (minutes) multiparous women (better indicated by lower values) 3 randomized very serious 3 serious 4 none MD 3. higher (50.89 lower to higher) Duration of first stage of labour (minutes) primiparous and multiparous women (better indicated by lower values) serious 4 none MD 8 lower (67.54 lower to 3.54 higher) Caesarean section 9 randomized serious 4 none 37/60 (5.%) 03/40 (4.3%) RR.7 (0.99 more per 000 (from to.63) 0 fewer to 7 more) Caesarean section primiparous women 6 randomized serious 4 none 08/38 (7.8%) 90/93 (7%) RR.5 ( more per 000 (from to.5) 8 fewer to 35 more) Caesarean section multiparous women 4.7% 7 more per 000 (from 6 fewer to 4 more) very serious none /795 (.5%) 6/678 (0.9%) RR.76 (0.65 to 4.76) 7 more per 000 (from 3 fewer to 33 more) 4

49 assessment patients Effect Amniotomy (normal progression at randomization) No amniotomy Caesarean section primiparous and multiparous women 3 randomized very serious none 7/444 (3.8%) 7/430 (.6%) RR.36 (0.99 more per 000 (from to 5.63) 0 fewer to 75 more) Dysfunctional labour 3 randomized serious 6 none 7/84 (7%) 358/853 (4%) RR 0.6 (0.44 to 0.8) 68 fewer per 000 (from 76 fewer to 35 fewer) Dysfunctional labour primiparous women 44.9% 80 fewer per 000 (from 8 fewer to 5 fewer) none /74 (9.7%) 50/83 (60.%) RR 0.49 (0.33 to 0.73) 307 fewer per 000 (from 63 fewer to 404 fewer) MODERATE Dysfunctional labour multiparous women none 36/66 (3.5%) 83/67 (3.%) RR 0.44 (0.3 to 0.6) 74 fewer per 000 (from 8 fewer to 4 fewer) MODERATE Dysfunctional labour primiparous and multiparous women none 69/50 (33.7%) 5/503 (44.7%) RR 0.75 (0.64 to 0.88) fewer per 000 (from 54 fewer to 6 fewer) MODERATE 4

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