Introduction
Methods
• Instrumental delivery (vacuum and forceps-assisted) |
• Emergency obstetric care, including Caesarean section |
• Induction of labour versus expectant management |
• Drugs for cervical ripening and induction of labour |
• Planned Caesarean section for breech presentation |
• Magnesium sulphate for treatment of pre-eclampsia/eclampsia or pre-term labour |
• Maternal hyperoxygenation for suspected impaired fetal growth |
• Amnioinfusion |
Results
Instrumental delivery (vacuum and forceps-assisted)
Background
Literature-based evidence
Source | Location and Type of Study | Intervention | Stillbirths/Perinatal Outcomes |
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Reviews and meta-analyses
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Johanson and Menon 1999 [7] | USA, Denmark, Sweden, England, South Africa. Meta-analysis (Cochrane). 7 RCTs included (N = 1800 women). | Assessed the effects of vacuum extraction vs. forceps on maternal and neonatal morbidity. | PMR: OR = 0.80 (95% CI: 0.18–3.52) [NS]. [3/901 vs. 4/899 in vacuum vs. forceps group, respectively]. |
Johanson and Menon 2000 [8] | Malaysia. Cochrane review. 1 RCT included with death as outcome (N = 72 women). | To assess the effects of soft (intervention) vs. rigid vacuum extractor cups (control) on perineal injury, fetal scalp injury and success rate. | Death: OR = 1.26 (95% CI: 0.08–20.85) [NS]. [1/32 vs. 1/40 in intervention and control groups, respectively]. |
Intervention studies
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Mustafa and Mustafa 2002 [10] | Pakistan (Multan). Nishtar Hospital. RCT. Consecutive patients (N = 931), of which 50 were selected (N = 27 ventouse group, N = 23 forceps). 50/931 consecutive patients were randomly selected either to forceps delivery (Group I) or ventouse extraction (Group II). | Compared the effects of ventouse vs. forceps delivery on maternal and perinatal outcome. | SBR: 0/27 vs. 1/23 in the vacuum and forceps groups, respectively. Success rate: 26/27 (96.30%) vs. 22/23 (95.65%) in vacuum and forceps groups, respectively. There was one failure in each category which was later on delivered by Caesarean section. |
Weerasekera et al. 2002 [9] | Sri Lanka. Tertiary care setting. RCT. Women (N = 442) undergoing instrumental delivery in the second stage (N = 238 forceps group, N = 204 vacuum). | Compared the impact of forceps vs. vacuum delivery on the stillbirth rate. | SBR or NMR: 1/238 vs. 1/204 in the forceps and vacuum groups, respectively; P > 0.05. There was no significant difference in babies needing resuscitation at birth or admission to neonatal intensive care unit. |
Observational studies
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Broekhuizen et al. 1987 [11] | USA. Tertiary care setting. Retrospective study. N = 256 vacuum extractions, and N = 300 randomly chosen forceps deliveries were analyzed. | Compared the impact of the vacuum extraction vs. forceps deliveries. | Death: one event in each group. |
Gachiri et al. 1991 [13] | Kenya (Nairobi). Kenyatta National Hospital. Prospective study. Vacuum extractions (N = 167). | Assessed the fetal and maternal outcome among women undergoing vacuum extraction | SBR: 6/167 (3.6%). PMR: 8/167 (4.8%). |
Mesleh 2002 [136] | Saudi Arabia. Retrospective review. Vaginal deliveries (N = 304) with instrument use (N = 258 ventouse group, N = 46 forceps). | Assessed the effects of vacuum vs. forceps deliveries on pregnancy outcomes. | SBR: 1/258 vs. 0/46 in the forceps and ventouse groups, respectively. The single stillbirth in the vacuum delivery group was due to intrapartum asphyxia and true knot in the umbilical cord. |
New meta-analysis
Conclusion
Emergency obstetric care, including Caesarean section
Background
Literature-based evidence
Source
|
Location and Type of Study
|
Intervention
|
Stillbirths/Perinatal Outcomes
|
---|---|---|---|
Quality and availability of obstetric care
| |||
Abdel-Latif et al; NICUS Group 2006 [57] | Australia (New South Wales and Australian Capital Territory). 10 neonatal intensive care units; stillbirth analysis done from other regional data. Retrospective analysis. Infants (N = 8654) < 32 wks' gestation born 1992–2002 (N = 1879 rural areas, N = 6775 urban). Regional SB analysis: N = 14,707 births. | Compared the impact of rural vs. urban residence and associated differentials in access to higher-level emergency obstetric care on perinatal mortality measures. | NMR (in NICU): adj. OR = 1.26 (95% CI: 1.07–1.48, P = 0.005) in rural vs. urban group. SBR: OR = 1.20 (95% CI: 1.09–1.32; P < 0.001). [727/3530 (20.6%) vs. 1991/11177 (17.8%) in rural and urban infants, respectively]. |
Cameron 1998 [25] | Australia (Far North Queensland). Atherton Hospital. Descriptive study. N = 2883 deliveries from 1981–1990 (N = 1974 public confinements, N = 909 private confinements). | Assessed annual obstetric audit data from 1981–1990 to compare publicly versus privately funded facilities. | PMR: 5.1/1000 vs. 5.5/1000 in public and private confinements, respectively. PMR (corrected): 9.6/1000 vs. 13.5/1000 vs. 16.9/1000 in public patients, Queensland (1987) and the Far North Statistical Division (1987), respectively. |
Gaffney et al. 1994 [48] | UK (Oxford). National Perinatal Epidemiology Unit. Case control study. N = 573 participants, of whom N = 141 cerebral palsy group (N = 257 controls) and N = 62 perinatal deaths (N = 119 controls). | Compared the frequency of events during labour and delivery, and the suboptimal care among cases (with perinatal deaths) vs. controls. | Intrapartum haemorrhage: OR = 5.3 (95% CI: 1.4–20.1) in cases of deaths vs. controls. Meconium stained amniotic fluid: OR = 12.3 (95% CI: 3.6–41.4) in cases of deaths vs. controls. Failure to respond to signs of severe fetal distress: OR = 26.1 (95% CI: 6.2 – 109.7) in cases of deaths vs. controls. |
Goldenberg et al. 2007 [3] | Review. Data from 51 countries (WHO and other sources). | Logistic regression analysis of measures of antenatal and obstetric care with perinatal outcomes. | Intrapartum SB: for each 1% increase in the percentage of women with at least 4 antenatal visits, the intrapartum SBR decreased by 0.16/1000 births (P < 0.0001). Intrapartum SB: as Caesarean section rates increased from 0 to 8%, for each 1% increase, the intrapartum SBR decreased by 1.61/1000 births. No relationship between Caesarean section and SBR in high-income countries. Stronger relationship between various measures of care with intrapartum versus antepartum SBR. |
Grzybowski et al. 1991 [59] | British Columbia (Queen Charlotte Islands). 21-bed hospital and medical clinic. Descriptive study. All women (N = 286) >20 wks' gestation delivering from 1984–88. 33% were primiparous, 20% native. N = 192 (67%) delivered locally, N = 33 (12%) transferred after admission for complications, N = 61 (21%) delivered elsewhere. | Assessed the PMR among women delivering at a small hospital without Caesarean section capability delivering <50 infants per year. | PMR: 20.8 (95% CI: 4.4–37.2); N = 6. Adverse perinatal outcome: 6.2% (12/193 newborns) (95% CI: 2.8–9.6%). |
Kiely et al. 1985 [56] | USA (New York City). Prospective study. All births of infants weighing > 1000 g from 1976–78. | Computed fetal mortality rates (adjusted for confounding by birth weight, gestational age, and other variables) at different levels of care. | Intrapartum SBR: 61% excess risk in Level 1 (community hospital) vs. Level 3 (perinatal intensive care) maternity units)(P > 0.01). Intrapartum SBR: 35% excess risk in Level 2 units (intermediate level of care) vs. Level 3 units (P = 0.06). |
Korhonen and Kariniemi 1994 [54] | Finland. Prospective study. Cases of emergency Caesarean section (N = 101). N = 60 cases study group, N = 41 controls. | Compared the impact on survival of cases with the operating team in the hospital (study group) vs. cases with the team on call (outside the hospital) (controls). | Live birth/neonatal survival rate: significantly higher when the operating team was in the hospital vs. on call outside the hospital), P = 0.05. SBR: 0/60 vs. 3/41 in intervention vs. controls, respectively . Hypoxic ischemic encephalopathy: 1/41 in the controls. |
Lansky et al. 2007 [50] | Brazil (Belo Horizonte). Population-based in 24 hospitals. Cohort study. N = 36,469 births, N = 419 perinatal deaths in 1999. | Compared PMR in hospitals contracted to the National Public Health System (SUS) with non-SUS hospitals. | PMR: OR = 2.92 (95% CI: 1.87–4.54) in the private-SUS vs. private non-SUS hospitals. PMR: OR = 1.81 (1.12–2.92) in the philanthropic-SUS vs. private non-SUS hospitals. PMR: OR = 1.30 (95% CI: 0.82–2.05) [NS] in the public SUS vs. private non-SUS hospitals. |
Lansky et al. 2007 [49] | Brazil (Belo Horizonte). Cohort study. N = 40,953 births and N = 826 perinatal deaths in 1999. | Compared PMR in hospitals linked to the national Universal Public Health System (SUS) vs. non-SUS hospitals. | PMR: highest in private and philanthropic SUS-contracted hospitals relative to private, non-SUS-contracted hospitals. Quality of care also associated with PMR. |
Leeman et al. 2002 [30] | USA (New Mexico). Native American hospital. Retrospective cohort study. All pregnant women (N = 1132) > 20 weeks gestation 1992–1996. N = 735 (64.7%) gave birth at the hospital without operative facilities; N = 290 (25.6%) were transferred before labour; and N = 107 (9.5%) were transferred during labour. | Compared the PMR at hospital lacking on-site Caesarean capability but with a high-risk obstetric population) with the nationwide PMR (historical controls). | PMR: 11.4/1000 (95% CI: 5.1–17.8) vs. 12.8/1000 at the hospital vs. nationwide, respectively [NS]. Caesarean section rate: 7.3% vs. 20.7% at the hospital and nationwide, respectively (statistically significant). Low Apgar score: 0.54% vs. 1.4% at the hospital and the nationwide, respectively (statistically significant). Resuscitation required: 3.4% vs. 2.9% at the hospital and nationwide, respectively [NS]. |
Longombe et al. 1990 [41] | Zaire. Rural setting. Retrospective study. Total deliveries (N = 9947) during a five-year period. N = 8476 (85.2%) normal deliveries; N = 1014 (10.2%) Caesarean; N = 484 (4.9%) complicated vaginal deliveries. | Compared the impact on perinatal mortality in the Caesarean group (study group #1) vs. complicated vaginal deliveries (study group #2) vs. normal deliveries (comparison group). | PMR: 3.67% vs. 2.29% vs. 0.75% in study group #1, study group #2, and comparison group, respectively. |
McClure et al; NICHD FIRST BREATH Study Group 2007 [137] | Democratic Republic of Congo, Guatemala, India, Zambia, Pakistan, Argentina. Population-based study, community-based. Prospective cohort study. N = 60,324 deliveries over an 18-month period. | Assessed care-based risk factors for SBR in different low-/middle-income countries. | SBR: 34/1000 vs. 9/1000 in Pakistan and Argentina, respectively. Maceration: 17.2% of stillbirths. Higher SBR significantly associated with less-skilled providers, out-of-hospital births, and low Caesarean section rates. |
Rautava et al. 2007 [51] | Finland. 14 level II (central) and 5 level III (university) hospitals. Retrospective national medical birth-register study. N = 2291 very pre-term infants (gestational age <32 weeks at birth or birth weight of ≤ 1500 g) born from 2000–2003. | Compared PMR between level II (central) and level III (university) hospitals. | IMR + SBR: 494/2291 infants (21.6%). IMR: 224/2021 (11.1%) among live-born infants. Both the total 1-year mortality and the 1-year mortality of live-born infants were higher in level II hospitals compared with level III hospitals. |
Steyn et al. 1998 [58] | South Africa. Hospital records. Retrospective analysis. N = 174,713 deliveries during 1975–1994), of which N = 22,773 were by Caesarean. | To describe trends in Caesarean section and PMR over the study period. | PMR: 34.7/1000 vs. 18.4/1000 in 1975 vs. 1994, respectively. The Caesarean section rate stayed constant at about 13% during this period. |
Practice of Caesarean section and impact on perinatal mortality
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Bottoms et al. 1997 [37] | USA. Academic referral centers with neonatal intensive care units. Prospective observational study. Singleton extremely low birth weight (LBW) infants (N = 713) over a one-year study period (N = 482 study group, N = 231 controls). | Compared the impact on PMR of provider willingness to perform Caesarean delivery at 24 weeks for indications of fetal distress (intervention) vs. provider unwillingness to provide early Caesarean for these indications (controls). | Neonatal survival: adj. OR = 3.7 (95% CI: 2.3–6.0); P = 0.0001 in the study vs. control group, respectively. Survival without serious neonatal morbidity: OR = 1.8 (94% CI: 1.0 = 3.3) [NS] in the study vs. control group, respectively. SB: 19.5% vs. 0% for 21 weeks vs. > 28 weeks, respectively. NMR: 78% vs. 3.3% in 21 weeks and 30+ weeks, respectively. |
De Muylder and Amy 1993 [40] | Zimbabwe (the Midlands Province). 12 hospitals. Prospective study. Deliveries from 1985–1986 in 12 hospitals (N = 19,363 deliveries/year), with Caesarean section rates ranging from 2.2–16.8%. | To assess the impact of high versus low Caesarean section rates on perinatal outcome. | PMR: 51.9/1000 vs. 39.7/1000 births in 6 hospitals with high rate of Caesarean section vs. 6 hospitals with high rate of instrumental delivery, respectively. Statistically significantly higher in hospitals with instrumental:Caesarean section ratio < 0.2. Caesarean section and PMR positively correlated: R2 = 0.429 (P = 0.021). |
Hankins et al. 2006 [36] | USA. Review. | To assess the impact on neonatal morbidity and mortality in a high-income country setting of allowing women to opt for delivery by elective Caesarean section at 39 weeks of gestation. | Extracted findings from reviewed studies: SBR: steady from 23–40 wks gestation, 5% of all stillbirths occurring at each week of gestation (Copper). SBR: 0.6/1000 vs. 1.9/1000 live births at 33–39 wks vs. >39 wks' gestation (Yudkin). SBR: 1.3–4.6/1000 live births from 37–41 wks' gestation (Fretts). Estimated prevention of SB associated with elective Caesarean for all births at 39 wks: 2/1000 living fetuses (6000 SBs prevented in the US each year). |
Iffy et al. 1994 [38] | Ireland (Dublin) and USA (Newark, New Jersey). 2 large hospitals. Observational study. N = 68479 births (excluding malformations). Caesarean section rates: 6% in Ireland hospital, 17.5% at USA hospital. | Compared the PMR associated with different Caesarean section rates at 2 different hospitals. | PMR: 611/50768 (12.0/1000) vs. 343/17711 (19.8/1000) in Newark vs. Dublin, respectively; P < 0.01. NMR: No impact. |
Ilesanmi et al. 1996 [47] | Nigeria (Ibadan). Oluyoro Catholic Hospital. Descriptive study. Breech singleton deliveries (N = 441 of 21,243 deliveries). | Compared the intrapartum stillbirth rate associated with breech (study group) vs. cephalic deliveries (controls). | Fresh SBR: 7.8% vs. 1.2% for breech and cephalic, respectively over the same time period. Caesarean section performed for 15.7% of breech singleton deliveries (indicatioN = fetal distress). |
McClure et al. 2007 [21] | 188 developed and developing countries. WHO data. Regression analysis. | To analyze correlation between SBR and multiple measures of antenatal and obstetric care (Caesarean section rates, skilled delivery attendance, and complete ANC). | SBR and MMR: strongly correlated, ~5 SBs for each maternal death. Ratio: 2:1 in least developed countries vs. 50:1 in the most developed countries. SBR: Decreased sharply as Caesarean section rates increased from 0 to about 10%, (same for MMR). SBR: No significant reductions associated with skilled attendance until coverage rates ~40%. SBR: No reductions associated with complete ANC until 60% coverage was achieved (modest reduction). |
Mekbib and Teferi 1994 [138] | Ethiopia (Addis Ababa). Hospital-based study. Retrospective review of hospital records. N = 11,657 consecutive deliveries 1987–1992). N = 645 Caesarean sections (5.5%). | Compared the impact PMR of deliveries by Caesarean section vs. all deliveries (controls). | PMR: 153.5/1000 (N = 99) vs. 67.5/1000 live births in Caesarean section group vs. rate for all deliveries respectively (P < 0.01). |
O'Driscoll et al. 1988 [39] | USA (Dallas, TX) and Ireland (Dublin). Retrospective analysis of hospital records from 1982–84. Pregnant women admitted to hospital (N = 24441 at Dublin; N = 22580 women in Dallas). | Compared the impact on PMR between a low Caesarean section rate hospital (Dublin) vs. a high Caesarean section rate hospital (Dallas). | CS rates: 482/8068 (6.0%) vs. 2001/10988 (18.0%) in Dublin vs. Dallas, respectively in 1983. [330/7782 (4.2%) vs. 2022/11592 (17.3%) in Dublin vs. Dallas, respectively in 1984.] PMR: 148/8199 (17.9/1000) vs. 161/11098 (14.5/1000) in Dublin vs. Dallas, respectively in 1983. [119/7879 (15.1/1000) vs. 207/11716 (17.8/1000) at Dublin and Dallas, respectively in 1984.] Intrapartum SB: 7-fold lower in Dallas compared to Dublin in 1983. Including 1982 & 1984, no significant difference in overall PMR despite 4 times as many Caesareans in Dallas as Dublin. |
Wright et al. 1991 [139] | Nigeria. Jos University Teaching Hospital (high-risk population). Descriptive study. N = 757 patients undergoing Caesarean section. | Assessed PMR among a case series of Caesarean section. | PMR: 235/1000 (N = 69 stillbirths and N = 107 early neonatal deaths). Caesarean section rate: 4.4%. |
Management of risk factors for stillbirth
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Abate et al. 2006 [140] | Ethiopia (Addis Ababa). Two teaching hospitals. Retrospective study. Eclamptic cases (N = 216) diagnosed, admitted and managed from October 1994 to September 1999. | To assess the stillbirth rate (SBR) and perinatal mortality rate (PMR) among women admitted to hospital who presented with or who developed eclampsia. | SBR: 44/216. Early neonatal deaths: 25/216. PMR: 312.2/1000 deliveries. |
Alessandri et al. [35] | Australia (Western Australia). Matched case-control study. Intrapartum stillbirths ≥1000 g (cases) and live born infants (controls) matched for year of birth (1980–1983), plurality, sex, birth weight, and race of mother. | To determine antenatal and intrapartum risk factors for intrapartum stillbirths at the population level. | Placental abruption: OR = 9.55 (95% CI: 2.09–43.69) in cases versus controls, respectively. Fetal distress: OR = 4.64 (95% CI: 1.92–11.19) in cases versus controls, respectively. Cord prolapse: OR = 10.00 (95% CI: 1.17–85.60) Placental problems (OR = 2.26, 95% CI: 1.13–4.52) Vaginal breech delivery: OR = 3.51 (95% CI: 1.40–8.80) and Emergency Caesarean section: OR = 2.15 (95% CI: 1.13–4.10). No antenatal risk factors predicted deaths. |
Basso et al. 2006 [141] | Norway. Population-based using data from the Medical Birth Registry. Longitudinal study. Singleton firstborn fetuses (N = 804,448) with Norwegian-born mothers born 1967–2003. | Compared the impact on perinatal outcomes of being born to preeclamptic (exposed) vs. non-preeclamptic (unexposed) mothers in the period from 1991–2003 vs. 1967–1978. | SBR: OR = 1.3 (95% CI: 1.1–1.7) in exposed vs. unexposed group, respectively from 1991–2003 vs. adj. OR = 4.2 (95% CI: 3.8–4.7) in exposed vs. unexposed group from 1967–78. Induction before 37 weeks for preeclampsia: 20% vs. 8% in 1991–2003 vs. 1967–78, respectively. |
Bhattacharyya et al. 1979 [142] | India. Prospective study. Patients (N = 60) with previous stillbirths. A majority (75%) had a history of repeated stillbirths, and responsible pathology was detected in 55% of the cases. | To assess the impact of active antepartum, intrapartum, and early postnatal care in women with previous stillbirths. | Live birth: 75%. |
Cruikshank and Linyear 1987 [53] | USA (Virginia). Perinatal audit. N = 108 term fetal deaths in 1983. | Assessed circumstances and management of term fetal deaths occurring in Virginia to determine potential preventability. | Preventable fetal death: 52/108 (48%) Risk factors for antepartum fetal death: maternal hypertension, diabetes, inadequate fetal surveillance, post-term pregnancy Major cause of intrapartum fetal death: delay between obvious fetal compromise onset and delivery. Incidence of preventable term stillbirth lower in larger hospitals. |
Onyiriuka 2006 [143] | Nigeria (Benin City). Retrospective, observational study. All babies born weighing > 4000 g. | Compared the fetal outcome in high birth weight babies (study group) vs. normal weight babies (controls). | Risk of fetal death higher in high birth weight babies (full text not available). Risk of Caesarean section higher in high birth weight babies (full text not available). |
Management and mortality of twin delivery, including impact of Caesarean section
| |||
Ananth et al. 2004 [144] | USA. Retrospective cohort study. Twin live births and stillbirths between 1989–91 and 1997 = 99 (N = 1,102,212). | Compared the changes in the SBR (≥22 weeks), labour induction, and Caesarean rates among twin births from 1989–91 and 1997–99. | SBR: RR = 0.52 (95% CI: 0.49–0.55) [13.9/1000 vs. 24.4/1000 in 1999 vs. 1989, respectively (48% decrease).] SBR excluding births weighing < 500 g and adjusting for changes in labour induction and Caesarean delivery: RR = 0.75 (95% CI: 0.72–0.79)(25% decrease). Labour induction: 13.8% vs. 5.8% in 1997–99 vs. 1989–91, respectively (138% increase). Caesarean delivery: 55.6% vs. 48.3% in 1997–99 vs. 1989–91, respectively (15% increase). |
Fakeye 1988 [145] | Nigeria (Ilorin). University of Ilorin Teaching Hospital. Descriptive study. Consecutive twin pairs (N = 622). N = 146 twin-1 and N = 192 twin-2 breech births. | Compared PMR between first and second twin breech infants. | SB and asphyxia (Apgar 1,2, or 3) high in both first and second twin breech infants. PMR: 13.7% vs. 18.8% for twin-1 and twin-2 breech, respectively. Corrected PMR: 9.3% vs. 12.4% for twin-1 and twin-2 respectively among infants weighing 2.0 kg or more. Twin-specific breech PMR lowest in 2.5–2.9 kg group (higher for smaller and larger twins). Breech-breech or primary breech managed by Caesarean section: lower PMR than vaginally delivered breech twin pairs. |
Rydhstrom and Ingemarsson 1991 [146] | Sweden (Stockholm). The National Medical Birth Registry. Matched case-control twin study. N = 273 twin pregnancies delivered 1973–1983 weighing 1500–2499 g. N = 91 pregnancies (cases), N = 182 controls. | To compare the Caesarean section rates between the cases where one or both twins died vs. controls with similar birth weight (+/- 100 g) and year of delivery (+/- 1 year). | Caesarean section rate: 20% vs. 50–65% in 1973–76 vs. 1981–83 respectively, with an increase for both cases and controls. No significant difference between groups [NS] |
Smith et al. 2005 [147] | UK (Scotland). Retrospective cohort study. All twin births (N = 8073) ≥36 weeks of gestation, excluding antepartum stillbirths and perinatal deaths due to congenital abnormality, 1985–2001; of which N = 1472 deliveries by planned Caesarean section. | To determine PMR among twins born at term in relation to mode of delivery. | PMR (2nd twin vs. 1st): OR = 5.00 (95% CI: 2.00–14.70) [6 vs. 30 deaths in first vs. second twins, respectively]. PMR (either twin): OR = 0.26 (95% CI: 0.03–1.03) [NS]. [2/1472 (0.14%) vs. 34/6601 (0.52%) deliveries in either twin by planned Caesarean section vs. other means, respectively; P = 0.05]. No association of birth order and PMR among those delivered by planned Caesarean section. |
Smith et al. 2007 [148] | UK (England, Northern Ireland and Wales). Retrospective cohort study. N = 1377 twin pregnancies with one twin dying perinatally (excluding malformations) and one surviving, 1994–2003. | To assess PMR based on birth order in twin pregnancies. | Birth order and the risk of death overall: OR = 1.0 (95% CI: 0.9–1.1) for the second twin [NS]. However, there was a highly significant interaction with gestational age (P < 0.001). PMR among 2nd twins born at term: OR = 2.3 (95% CI: 1.7–3.2, P < 0.001). Higher risk for vaginal birth (OR = 4.1, 95% CI: 1.8 to 9.5) compared with Caesarean section (OR = 1.8, 95% CI: 0.9 to 3.6); P = 0.10. PMR among 2nd twins at term associated with intrapartum anoxia or trauma (OR = 3.4, 95% CI: 2.2 – 5.3). |
VBAC vs. repeat Caesarean section
| |||
Bahtiyar et al. 2006 [149] | USA. Perinatal mortality data (1995 to 1997). Cross-sectional study. Deliveries of singleton term pregnancies (N = 11,061,599) in women 15–44 years collected 1995–97. Caesarean delivery rate was 19.6%. | Compared the impact on SBR among pregnant women with a prior Caesarean delivery (intervention) vs. women with no prior Caesarean delivery (control). | Crude fetal death (miscarriage+SB): 1.3/1000 vs. 1.5/1000 births in intervention vs. control groups, respectively. Adjusted fetal death (miscarriage+SB): 0.4/1000 vs. 0.6/1000 births in intervention vs. control groups, respectively.
Subset of women with only 1 prior delivery:
Fetal death (miscarriage+SB): RR = 0.90 (95% CI: 0.76–1.06) [NS]. [0.7/1000 vs. 0.8/1000 births in intervention vs. control groups, respectively]. |
Kumar et al. 1996 [42] | Western Australia. Retrospective study. Women (N = 79) with prior Caesarean section. N = 33 (41.8%) women agreed to a trial of vaginal birth. N = 29 women had labour induced and 26 (89.7%) of them had a successful vaginal delivery. | To assess the PMR in women attempting vaginal birth after Caesarean section (VBAC). | PMR: 0/79. Vaginal delivery rate: 87.9% in women undergoing a trial of vaginal birth. Caesarean section for fetal distress: 4/33 (12.1%). Caesarean section rate: fell from 32.2% to 11% in hospital during the study period. |
Meehan et al. 1989 [43] | Ireland (Galway). Regional Hospital. Retrospective analysis. N = 27,072 babies born 1972–1982. N = 1498 patients with prior Caesarean section, including N = 654 (44%) with repeat elective Caesarean section and N = 844 (56%) with VBAC. | Compared the impact on PMR among women with prior Caesarean section according to the mode of delivery: elective Caesarean section, VBAC, and emergency Caesarean section). | PMR: 30.3/1000 (N = 46) vs. 22.5/1000 in all women with prior Caesarean section vs. overall hospital population, respectively. PMR: 10.6/1000 vs. 90.3/1000 in those delivered by elective Caesarean section vs. those by emergency Caesarean section (statistically significant) Successful vaginal delivery occurred in 702 (83%) patients and 142 (17%) had emergency repeat operations. Corrected PMR was twice as high in the trial of scar group. |
Mock et al. 1991 [45] | West Africa. Rural hospital based. Descriptive study. Women (N = 220) with prior Caesarean section delivering 1987–1990. N = 169 patients given a trial of labour, of whom vaginal delivery was achieved in 111 (66%). | Compared the impact on maternal and fetal outcome between women given a trial of labour and those given elective repeat Caesarean section. | PMR: [NS] |
Nyirjesy et al. 1992 [44] | Northeastern Zaire. Rural referral hospital. Descriptive study. Women (N = 33) with previous Caesarean given trial of labour in 1989–1990, of which 22 (67%) had successful vaginal deliveries. | Assessed the PMR in women given a trial of labour (study group) vs. the overall rate for the institution (controls). | PMR: 60.1/1000 (study group) [NS] compared to controls. |
van Roosmalen 1991 [46] | Tanzania. 2 rural hospitals. Observational study. N = 134 women with a history of previous Caesarean section, of which N = 87 had a vaginal delivery after a trial of labour. | Compared PMR in women with a previous Caesarean birth in relation to the indication of the previous operation, a history of previous vaginal delivery and the number of previous operations. | PMR: 9/64 (14%) vs. 4/45 (9%) vs. 0/25 (0%) where the indication for previous Caesarean was CPD vs. nonrecurrent vs. unknown, respectively [NS]. PMR: 3/43 (7%) vs. 10/91 (11%) in women without previous vaginal birth vs. with previous vaginal respectively [NS]. PMR: 10/114 (9%) vs. 3/20 (14%) in women with one previous Caesarean vs. more than one Caesarean, respectively [NS]. |
Availability and practice of Caesarean section
Quality of obstetric care
Conclusion
Induction of labour (versus expectant management)
Background
Literature-based evidence
Source | Location and Type of Study | Intervention | Stillbirths/Perinatal Outcomes |
---|---|---|---|
Reviews and meta-analyses
| |||
Dare et al. 2006 [67] | Canada, Scotland, Netherlands, Israel, other countries. Meta-analysis (Cochrane). 5 RCTs included (N = 5870 participants). | To assess the effects of planned early birth (intervention) vs. expectant management (controls) for women with term pre-labour rupture of membranes on fetal, infant and maternal wellbeing. | Fetal death (miscarriage + SB)/PMR: OR = 0.46 (95% CI: 0.13–1.66) [NS]. [3/2946 vs. 7/2924 in intervention and control groups, respectively]. |
Dodd et al. 2003 [70] | Japan (Tokyo). Cochrane review. 1 RCT included (N = 72 participants). | To assess a policy of elective delivery from 37 weeks' gestation (intervention) vs. an expectant approach (controls) for women with an otherwise uncomplicated twin pregnancy. | PMR: RR not estimable. [0/34 vs. 0/38 in intervention and control groups, respectively]. |
Gülmezoglu et al. 2006 [64] | Thailand, USA, Turkey, Norway, Canada, UK, India, Finland, China. Meta-analysis (Cochrane). 12 RCTs included (N = 5939 women). | To assess the impact of a policy of labour induction at term or post-term (intervention) vs. awaiting spontaneous labour or later induction of labour (controls). | SBR: RR = 0.28 (95% CI: 0.05–1.67) [NS]. [0/2986 vs. 4/2953 in intervention and control groups, respectively]. PMR: RR = 0.30 (95% CI: 0.09–0.99). [1/2986 vs. 9/2953 in intervention and control groups, respectively]. |
Irion et al. 1998 [63] | USA, unknown. Meta-analysis (Cochrane). 2 RCTs included (N = 99 women). | To assess the effects of a policy of labour induction (intervention) vs. expectant management (controls) for suspected fetal macrosomia on method of delivery and maternal or perinatal morbidity. | PMR: RR not estimable. [0/49 vs. 0/50 in intervention and control groups, respectively]. |
Boulvain et al. 2001 [65] | USA. Cochrane review. 1 RCT included (N = 200 women). | To assess the effect of a policy of elective delivery (intervention) vs. expectant management (controls) in term diabetic pregnant women, on maternal and perinatal mortality and morbidity. | PMR: RR not estimable. [0/100 vs. 0/100 in intervention and control groups, respectively]. |
Intervention studies
| |||
Chattopadhyay et al. 1986 [71] | Saudi Arabia. Prospective, controlled study. Grand multiparae (N = 300) between 38 and 42 weeks' gestation (N = 150 intervention group, N = 150 controls). | To compare the impact on labour characteristics and outcome in women where labour was electively induced by intracervical prostaglandin E2 tablets (intervention) vs. women who went into labour spontaneously. | SBR: 0/150 vs. 4/150 in intervention and control groups, respectively. Mean duration of the active phase of labour: 2.1 +/- 0.79 h vs. 2.8 +/- 0.47 h vs. 4.7 +/- 2.2 h in women who delivered on the first day of induction vs. on the second day vs. the controls. Similarly, the mean duration of the second and third stage was longer in the controls. |
da Graca Krupa et al. 2005 [69] | Brazil (Campinas City). Public university hospital. RCT. N = 150 pregnancies, half of them allocated to each group. | To compare the effectiveness of immediate induction of labour with vaginal misoprostol (intervention) vs. expectant management for 24 hours followed by oxytocin induction (controls) in women with premature rupture of membranes at term (term PROM). | PMR: 0/75 in each group. |
Observational studies
| |||
Duff et al. 2000 [150] | Ireland. Northern Ireland Maternity System (NIMATS). Retrospective comparative study. N = 3262 women who delivered during 1994 – 96 (N = 1008 intervention group, N = 2254 controls). | Compared the impact on Caesarean section rates and Apgar scores in women who had labour induced (intervention) vs. those in whom the labour commenced spontaneously (controls). | Caesarean section rate: 12.2% vs. 7.06% in intervention and control groups, respectively [NS] (Chi sq = 4.39, p <= 0.2). 1 minute Apgar score: 7.78 vs. 7.9 in intervention and control groups, respectively, t = 2.9, P <= 0.01. 5 minute Apgar score: 8.99 vs. 9.05 in intervention and control groups, respectively, t = 2.42, P <= 0.02). |
Post-term pregnancy/prevention of obstructed labour due to cephalo-pelvic disproportion
Premature rupture of membranes (PROM)
Multiple pregnancy
Grand multiparity
New meta-analysis
Conclusion
Drugs for cervical ripening and induction of labour
Background
Literature-based evidence
Source | Location and Type of Study | Intervention | Stillbirths/Perinatal Outcomes |
---|---|---|---|
Reviews and meta-analyses
| |||
Kelly et al. 2003 [90] | UK, Austria, New Zealand, Singapore, USA, Pakistan, Canada. Meta-analysis (Cochrane). 8 RCTs included (N = 3648 women). | To compare the effects of vaginal prostaglandins E2 (all regimens) for third trimester cervical ripening or induction of labour (intervention) vs. placebo/no treatment (controls). | PMR: RR = 0.56 (95% CI: 0.14–2.22) [NS]. [2/1833 vs. 4/1815 in the intervention and control groups, respectively]. |
Boulvain et al. 2008 [62] | USA, Europe, Africa, UK, Italy. Meta-analysis (Cochrane). 4 RCTs included (N = 1081 women). | Compared the impact on perinatal mortality of intracervical prostaglandin (prostaglandin E2) (intervention) vs. placebo/no treatment (controls) for third trimester cervical ripening and induction of labour. | PMR: RR = 0.20 (95% CI: 0.01–4.05) [NS]. [0/587 vs. 2/494 in intervention and control groups, respectively]. |
Hutton et al. 2001 [92] | 2 RCTs. Zimbabwe, Australia. Cochrane review. 2 RCTs included (N = 25 women). | To assess the effects of extra-amniotic prostaglandin (PGF2 alpha) (intervention) for third trimester cervical ripening or induction of labour vs. extra amniotic placebo gel (controls). | PMR: RR = 2.06 (95% CI: 0.09–46.11) [NS]. [1/15 vs. 0/10 in intervention and control groups, respectively]. |
Hofmeyr et al. 2003 [79] | Chile, Zimbabwe, USA, Canada, Jamaica, Malaysia. Meta-analysis (Cochrane). 7 RCTs included (N = 268 women). | To assess the effects of vaginal misoprostol for third trimester cervical ripening or induction of labour (intervention) vs. vaginal prostaglandin (controls). | PMR: RR = 2.85 (95% CI: 0.12–68.95) [NS]. [1/136 vs. 0/132 in intervention and control groups, respectively]. |
Neilson 2000 [94] | France, Sweden. Meta-analysis (Cochrane). 2 RCTs included (N = 68 women). | To assess the effects of mifepristone (all doses) for third trimester cervical ripening or induction of labour (intervention) vs. placebo/no treatment (controls). | PMR: RR not estimable. [0/40 vs. 0/28 in intervention and control groups, respectively]. |
French 2001 [89] | India, Denmark. Cochrane review. 2 RCTs included (N = 35 women). | To assess the effects of oral prostaglandin E2 for third trimester induction of labour (intervention) vs. intravenous oxytocin (controls) on perinatal mortality. | PMR: RR not estimable. [0/15 vs. 0/20 in intervention and control groups, respectively]. |
Luckas et al. 2000 [93] | USA, UK, Denmark, Belgium and Netherlands. Meta-analysis (Cochrane). 11 RCTs included (N = 990 women). | To assess the effects of intravenous prostaglandin for third trimester cervical ripening or induction of labour (intervention) vs. IV oxytocin (controls). | PMR: RR = 3.59 (95% CI: 0.60–21.53) [NS]. [4/499 vs. 0/491 in intervention and control groups, respectively]. |
Alfirevic 2006 [75] | Hong Kong, Switzerland, South Africa, UK, Spain, Canada, USA. Meta-analysis (Cochrane). 17 RCTs included (N = 1508 women). | To assess the effectiveness and safety of oral misoprostol used for labour induction in women with a viable fetus in the third trimester of pregnancy (intervention) vs. vaginal prostaglandin (controls). | PMR: RR = 0.60 (95% CI: 0.08–4.50) [NS]. [data from 4 RCTs; 1/756 vs. 2/752 in intervention and control groups, respectively]. |
Intervention studies
| |||
Elhassan et al. 2005 [85] | Sudan. Non-blinded RCT. N = 140 patients (N = 70 intervention, N = 70 controls). | Assessed the impact of vaginal misoprostol, 50 μg, six hourly until initiation of labour or maximum of 4 doses (intervention) vs. IV infusion of oxytocin at 2 mU/min, doubled at 30-minute intervals until the appropriate contraction pattern obtained or dose increased to a maximum of 20 mU/minute and maintained as such (controls). | Neonatal outcomes (birth weight, Apgar score and SBR): [NS] |
Garry et al. 2003 [80] | USA. RCT. Singleton gestations (N = 200) with an indication for cervical ripening and induction of labour. | Compared the impact of 50 μg of vaginal misoprostol every 3 h (intervention) vs. a 10-mg prostaglandin E2 vaginal insert every 12 h for a maximum of 24 h (controls). | Neonatal outcomes: [NS] Vaginal delivery <12 hr: 44% vs. 12% in misoprostol vs. prostaglandin E2 group, respectively (P < 0.0001) Vaginal delivery <24 hr: 68% vs. 38 in misoprostol vs. prostaglandin E2 group, respectively (P < 0.001). Caesarean delivery for fetal distress: 71.4% (20/28) vs. 40% (14/35) in misoprostol group vs. prostaglandin E2 group (P = 0.03). |
Jindal et al. 2007. [87] | India. Quasi-RCT. N = 100 women (N = 50 intervention group, N = 50 controls). | Compared the impact of 50 μg of vaginal misoprostol 4 hourly for a maximum of six doses (intervention) vs. transcervical Foley catheter with simultaneous intravenous oxytocin (controls). | SBR: 1/50 vs. 0/50 in intervention and control groups, respectively. |
Lokugamage et al. 2003 [81] | UK. Hospital based. RCT. N = 191 patients. | Compared the impact of 50 μg vaginal misoprostol initially then a further identical dose 6 hrs later (intervention) vs. 2 mg vaginal prostaglandin E2 initially followed by 1 mg 6 hrs later, over a period of 24 hrs (controls). All participants not in labour after 24 hrs received prostaglandin E2 alone as per hospital protocol. | Neonatal outcome: [NS] Induction-to-delivery interval: 1047 vs. 1355 min (P = 0.01) in intervention and control groups, respectively. Delivery <12 hrs: 35.4% vs. 18.9%, (P = 0.02) in intervention and control groups, respectively. Delivery <24 hrs: 83.3% vs. 63.3%, (P = 0.01) in intervention and control groups, respectively. Oxytocin augmentation: [NS] (P = 0.47), Tachysystole: [NS] (P = 0.32) and Hyperstimulation syndrome: [NS] (P = 0.82). |
Majoko et al. 2002 [151] | Zimbabwe. RCT. N = 152 women admitted for induction of labour (N = 76 in each group). | Compared the impact of vaginal misoprostol (intervention) versus extra-amniotic prostaglandin F2α gel (controls). | SBR: 1/76 in each group due to asphyxia (both mothers induced for pre-eclampsia; deaths resulting from inadequate response to fetal distress). |
Meyer et al. 2005 [86] | USA. RCT. N = 84 patients. | Compared the impact of 0.25μg misoprostol vaginally (intervention) vs. 0.5 mg prostaglandin E2 gel intracervically (controls), the evening before oxytocin induction. | Neonatal outcome: [NS] Caesarean rate: 9/42 vs. 8/42 in intervention and control groups, respectively [NS] |
Papanikolaou et al. 2004 [84] | Greece. RCT. Nulliparous pregnant women (N = 163) with an unfavorable cervix and > 285 days of gestation (N = 80 intervention group, N = 83 controls). | Compared the efficacy of 50 μg vaginal misoprostol (intervention) versus 3 mg prostaglandin E2 (controls), administered every 9 hrs for a maximum of three doses for elective induction of labour. | SBR or PMR: 0/80 vs. 1/83 (1.2%) in intervention and control groups, respectively [NS]. |
Rowlands et al. 2001 [83] | Australia. RCT. N = 126 women recruited to the study (N = 63 in each group). | Compared the effect on neonatal outcomes of vaginal prostaglandin E2 (group 1) vs. vaginal misoprostol (controls) for cervical priming prior to induction of labour. | Neonatal outcome (low cord pH, Apgar score at delivery or admission to the neonatal special care nursery): [NS] |
Sahin et al. 2002 [88] | Turkey. RCT. N = 100 pre-eclamptic women with a modified Bishop score of = 4 (N = 50 in each group). | Compared the impact of 50 μg vaginal misoprostol 4 times at 4 hour intervals (intervention) vs. oxytocin infusion for induction of labour starting from 1 mIU/per min, increasing it every 30 min with 2 mIU/min increments up to maximum of 30 mIU/min (controls). | Intrapartum SB: 0/50 in both groups. |
Sahraoui et al. 2005 [91] | Tunisia. RCT. All uncomplicated pregnancies that reached 41 weeks'gestation with a Bishop score of < or = 4. | Compared the impact on fetal outcomes of cervical prostaglandin E2 gel for cervical ripening (intervention) vs. control. | Caesarean rates: [NS] Rates of admission into the neonatal unit and fetal outcomes: [NS] |
Van Gemud et al. 2004 [82] | The Netherlands. Labour wards of one university hospital and two teaching hospitals. RCT. Women (N = 681) with indication for labour induction at > or = 36 weeks of gestation, singleton pregnancy and no previous Caesarean section. | Compared the impact on pregnancy outcomes of misoprostol (25 mcg, hospital-prepared capsule) in the posterior vaginal fornix, every four hours, maximum three times daily (intervention) vs. prostaglandin E2 gel every four hours (controls). Oxytocin was administered if necessary | Neonatal deaths: (excluding malformations): 0 in both groups. Adverse neonatal outcome: 21% vs. 23% in intervention and control groups, respectively [NS]. Median induction-delivery interval: 25 vs. 19 h in intervention and control groups, respectively (P = 0.008). Caesarean rate: RR = 0.8 (95% CI: 0.6–1.04) [NS]. [16.1% vs. 21% in intervention and control groups, respectively]. Admission to NICU: RR = 0.7 (95% CI: 0.5–0.98). [19% vs. 26% in intervention and control groups, respectively]. |
Oral misoprostol versus placebo, other prostaglandins, or vaginal misoprostol
Vaginal misoprostol versus placebo, other prostaglandins, or oxytocin
Oral prostaglandins versus IV oxytocin
Intracervical prostaglandins versus placebo
Vaginal prostaglandins versus placebo
Extra-amniotic prostaglandins versus placebo
Intravenous prostaglandins versus intravenous oxytocin
Mifepristone versus placebo
New meta-analysis
Vaginal misoprostol versus prostaglandin E2
Conclusion
Planned Caesarean section for breech presentation
Background
Literature-based evidence
Source | Location and Type of Study | Intervention | Stillbirths/Perinatal Outcomes |
---|---|---|---|
Reviews and meta-analyses
| |||
Hofmeyr et al. 2003 [97] | USA. Meta-analysis (Cochrane). 3 RCTs included (N = 2388 women). | To assess the effects of planned Caesarean section for singleton breech presentation at term (intervention) vs. planned vaginal delivery on measures of pregnancy outcome. | PMR/NMR (excluding fatal malformations): RR = 0.29 (95% CI: 0.10–0.86). [3/1166 vs. 14/1222 in intervention and control groups, respectively]. |
Intervention studies
| |||
Irion et al. 1998 [99] | Switzerland (Geneva). University hospital. Cohort study. N = 705 consecutive singleton term breech presentations (N = 385 planned vaginal deliveries, N = 320 planned Caesarean sections). | Compared the impact on neonatal mortality of planned vaginal delivery vs. elective Caesarean section in term breech presentations. | NMR (all major malformations): RR = 3.33 (95% CI: 0.37–29.60). [1% vs. 0.3% in planned vaginal vs. Caesarean groups, respectively; P = 0.38]. |
Molkenboer et al. [100] | The Netherlands. 2 centres. Retrospective matched cohort study. N = 1119 deliveries between July 1998 and April 2000 (N = 373 breech between 37(+0) and 41(+6) weeks, N = 746 cephalic position). | Compared the impact on perinatal mortality in babies with breech presentation (exposed) vs. those with cephalic presentation (unexposed). | PMR: 0 in both groups. Planned Caesarean: 23.3% vs. 3.5% in breech vs. cephalic deliveries, respectively; P < 0.001. Emergency Caesarean: 29.2% vs. 8.8% in exposed vs. unexposed groups, respectively; P < 0.001. |
Nalliah et al. 2009 [152] | Malaysia (Ipoh). Hospital based study. Retrospective analysis. N = 4886 breech presentations from 1992–2004, of which 3725 were evaluated. | Compared perinatal mortality among breech births delivered vaginally versus by Caesarean section. | PMR: Mode of delivery did not improve PMR in breech cases. |
Conclusion
Magnesium sulphate supplementation for pre-eclampsia/eclampsia and pre-term labour
Background
Literature-based evidence
Source | Location and Type of Study | Intervention | Stillbirths/Perinatal Outcomes |
---|---|---|---|
Magnesium sulphate for treatment of pre-eclampsia and eclampsia | |||
Reviews and meta-analyses
| |||
Duley 2003 [108] | Bangladesh, South Africa, USA, Malaysia. Meta-analysis (Cochrane). 5 RCTs included (N = 9,961 women). | To assess the effects of magnesium sulphate for pre-eclampsia (intervention) vs. placebo or no anti-convulsant (controls) on the women and their children. | SBR: RR = 0.99 (95% CI: 0.87 – 1.12) [NS]. [424/5003 vs. 426/4958 in intervention and control groups, respectively]. PMR: RR = 0.98 (95% CI: 0.88 – 1.10) [NS]. [538/4655 vs. 541/4604 in intervention and control groups, respectively]. |
Duley et al. 2000 [109] | India. Meta-analysis (Cochrane). 2 RCTs included (N = 177 women). | To compare the effects of magnesium sulphate (intervention) vs. those of lytic cocktail (controls) when used for the care of women with eclampsia. | SBR: RR = 0.55 (95% CI: 0.26 – 1.16) [NS]. [9/89 vs. 16/88 in intervention and control groups, respectively]. NMR: RR = 0.39 (95% CI: 0.14 – 1.06) [NS]. [5/90 vs. 13/93 in intervention and control groups, respectively]. |
Duley et al. 2003 [104] | South Africa, India. Meta-analysis (Cochrane). 2 RCTs included (N = 665 women). | To assess the effects of magnesium sulphate (intervention) vs. phenytoin (controls) when used for the care of women with eclampsia. | SBR: RR = 0.83 (95% CI: 0.61 – 1.13) [NS]. [57/325 vs. 72/340 in intervention and control groups, respectively]. PMR: RR = 0.85 (95% CI: 0.67 – 1.09) [NS]. [84/325 vs. 103/340 in intervention and control groups, respectively]. NMR: RR = 0.95 (95% CI: 0.59 – 1.53) [NS]. [29/325 vs. 32/340 in intervention and control groups, respectively]. |
Duley et al. 2003 [103] | Malaysia, Zimbabwe, Africa, Asia and South America. Meta-analysis (Cochrane). 4 RCTs included (N = 756 women). | To assess the effects of magnesium sulphate (intervention) vs. diazepam (controls) when used for the care of women with eclampsia. | SBR: RR = 0.89 (95% CI: 0.63 – 1.26) [NS]. [51/385 vs. 55/371 in intervention and control groups, respectively]. PMR: RR = 1.04 (95% CI: 0.80 – 1.36) [NS]. [87/379 vs. 80/366 in intervention and control groups, respectively]. NMR: RR = 1.34 (95% CI: 0.84 – 2.14) [NS]. [38/364 vs. 27/352 in intervention and control groups, respectively]. |
Magnesium sulphate for threatened pre-term labour.
| |||
Reviews and meta-analyses
| |||
Crowther et al. 2002 [105] | USA. Meta-analyses (Cochrane). 7 RCTs included (N = 635 women). | To assess the effectiveness and safety of magnesium sulphate therapy (intervention) vs. placebo, no placebo or alternative tocolytic therapy (controls) given to women in threatened pre-term labour with the aim of preventing pre-term birth and its sequelae. | Fetal deaths (miscarriage+SB): RR = 5.70 (95% CI: 0.28 – 116.87) [NS]. [2/293 vs. 0/342 in intervention and control groups, respectively]. |
Crowther and Moore 1998 [111] | USA. Cochrane review. 1 RCT included (N = 50 women). | To assess the effects of magnesium maintenance therapy (intervention) vs. placebo/no treatment (controls) on preventing pre-term birth after threatened pre-term labour. | Death before hosp discharge: RR = 5.00 (95% CI: 0.25 – 99.16) [NS]. [2/25 vs. 0/25 in intervention and control groups, respectively]. |
Doyle et al. 2007 [110] | Australia, New Zealand, France, USA. Meta-analysis (Cochrane). 4 RCTs included (N = 3,701 women). | To assess the effectiveness and safety of magnesium sulphate as a neuroprotective agent (intervention) vs. placebo or no placebo (controls) when given to women considered at risk of pre-term birth. | Fetal death (miscarriage + SB): RR = 0.98 (95% CI: 0.78 – 1.24) [NS]. [123/1864 vs. 125/1837 in intervention and control groups, respectively]. |
Intervention studies
| |||
Rouse et al. 2008 [112] | USA. Multicentre. RCT. N = 2241 women 24–31 weeks of gestation deemed at high risk of pre-term labour. | Compared the impact of IV magnesium sulphate (a loading dose of 6 g infused for 20 to 30 minutes, followed by a maintenance infusion of 2 g per hour) (intervention) with identical-appearing placebo (controls). | SBR+IMR): RR = 1.12 (95% CI: 0.85 – 1.47); P = 0.41 [NS]. [99/1041 (9.5%) vs. 93/1095 (8.5%) in intervention and control groups, respectively]. Moderate or severe cerebral palsy: RR = 0.55 (95% CI: 0.32–0.95); P = 0.03. [20/1041 (1.9%) vs. 38/1095 (3.5%) in intervention and control groups, respectively]. |
Magnesium sulphate for treatment of pre-eclampsia and eclampsia
Magnesium sulphate for prevention of preterm birth
Conclusion
Maternal hyperoxygenation for suspected impaired fetal growth
Background
Literature-based evidence
Source | Location and Type of Study | Intervention | Stillbirths/Perinatal Outcomes |
---|---|---|---|
Reviews and meta-analyses
| |||
Say et al. 2003 [119] | Italy, UK, South Africa. Meta-analysis (Cochrane). 3 RCTs included (N = 94 women). | To assess the effects of maternal oxygen therapy (intervention) vs. management without additional oxygen (controls) in suspected impaired fetal growth on fetal growth and perinatal outcome. | PMR: RR = 0.50 (95% CI: 0.32 – 0.81). [15/46 vs. 31/48 in intervention and control groups, respectively]. |
Intervention studies
| |||
Battaglia et al. 1994 [120] | Italy (Modena). Tertiary referral hospital (University of Modena). Quasi-RCT. N = 38 patients with intrauterine growth retardation (N = 18 intervention group, N = 20 controls). | Compared the impact on fetal survival of bed rest plus humidified 55% oxygen at a rate of 8 l/min continuously (intervention) vs. bed rest (plus anti-hypertensive treatment, when necessary). Ultrasound assessment of amniotic fluid volume was performed on alternate days, and the fetal abdominal circumference was evaluated weekly. Doppler analysis of fetal/maternal circulation was performed upon the patient's arrival at hospital, after 12 h, and thereafter on alternate days until parturition. | PMR: No deaths. |
Conclusion
Amnioinfusion
Background
Literature-based evidence
Source | Location and Type of Study | Intervention | Stillbirths/Perinatal Outcomes |
---|---|---|---|
Reviews and meta-analyses
| |||
Hofmeyr 2002 [124] | South Africa, Zimbabwe, USA. Meta-analysis (Cochrane). 8 RCTs included (N = 1,481 women). | To assess the effects of amnioinfusion for meconium-stained liquor (intervention) vs. no amnioinfusion (controls) on perinatal outcome. | PMR: RR = 0.34 (95% CI: 0.11 – 1.06) [NS]. [4/727 vs. 12/754 in intervention and control groups, respectively]. |
Hofmeyr 1998 [125] | USA. Meta-analysis (Cochrane). 8 RCTs included (N = 584 women). | To assess the effects of amnioinfusion (intervention) vs. no amnioinfusion (controls) on maternal and perinatal outcome for potential or suspected umbilical cord compression or potential amnionitis. | PMR: RR = 0.51 (95% CI: 0.11 – 2.24) [NS]. [2/301 vs. 4/283 in intervention and control groups, respectively]. |
Intervention studies
| |||
Ashfaq 2004 [130] | Pakistan (Karachi). Jinnah Postgraduate Medical Centre. Matched case control study. N = 400 patients between 1st January 1998 to 31st December 2000 (N = 200 intervention group, N = 200 controls) with meconium staining of liquor. | Compared the impact on fetal outcome of amnioinfusion (intervention) vs. no amnioinfusion (controls) in cases of meconium staining. | SBR: 0/200 vs. 8/200 (4%) in intervention and control groups, respectively. PMR/perinatal morbidity: 6% vs. 14% in intervention and control groups, respectively (statistically significant). |
Das et al. 2007 [133] | India (West Bengal). Prospective comparative study. Women (N = 150) who were in labour and had meconium-stained amniotic fluid (N = 50 intervention group, N = 100 controls). | Compared the impact of transcervical amnioinfusion (intervention) vs. standard care (controls). | PMR: RR = 0.31 (95% CI: 0.07 – 1.31) [NS]. [2/50 (4%) vs. 13/100 (13%) in intervention and control groups, respectively]. |
Fraser et al. 2005 [129] | 13 countries. Multicentered (56 centers). RCT. Pregnant women (N = 1998) in labour at 36 or more weeks of gestation who had thick meconium staining of the amniotic fluid. (81.3% of these women did not have recurrent variable decelerations in fetal heart rate on monitoring). N = 995 intervention group, N = 1003 controls). | Compared the impact of transcervical amnioinfusion (800 ml saline over 40 min, followed by 2 ml/min to 1500 ml max; intervention) vs. standard care (no amnioinfusion) (controls). Women were assessed by continuous monitoring of intrauterine pressure or by uterine palpation at 15-minute intervals for signs of uterine overdistention or hypertonic contractions. Continuous electronic fetal heart-rate monitoring was performed in both groups. | PMR: RR = 1.00 (95% CI: 0.29 – 3.45) [NS]. [N = 5 (0.5%) vs. N = 5 (0.5%) in intervention and control groups, respectively]. PMR, moderate or severe meconium aspiration syndrome, or both: RR = 1.26 (95% CI: 0.82 – 1.95) [NS]. [44/986 (4.5%) vs. 35/989 (3.5%) in intervention and control groups, respectively]. |
Kirubamani 2000. [132] | India. RCT. N = 50 labouring women with clinically analysed meconium (light, moderate, thick) (N = 30 intervention group, N = 20 controls). | Compared the impact on perinatal mortality of amnioinfusion with warm saline at room temperature, along with standard obstetric care (intervention) vs. standard care only without amnioinfusion (controls). | PMR: 0/30 vs. 1/20 in intervention and control groups, respectively. |
Mukhopadhyay et al. 2006 [153] | India. Quasi-RCT. N = 200 women (N = 100 in each group). | Compared the impact on perinatal mortality of intraamniotic infusion of normal saline (intervention) vs. no amnioinfusion (controls). | PMR: 2/93 (2.1%) vs. 3/93 (3.2%) in intervention and control groups, respectively; P = 0.9748. |
Rathore et al. 2002 [134] | India. RCT. Women (N = 200) during labour with meconium stained amniotic fluid (N = 100 in each group). | Assessed the effect on perinatal deaths of amnioinfusion (intervention) vs. no amnioinfusion (controls). | PMR: 2 vs. 5 deaths in intervention and control groups, respectively. SBR: 1 death in each group. Early NMR (excluding malformations): 0 vs. 1 death in intervention and control groups, respectively. |
Observational studies
| |||
Chhabra et al. 2007 [128] | India. Case-control study. Pregnant women (N = 100) with oligohydramnios (N = 50 study group, N = 50 controls). | Compared the impact of antepartum transabdominal amnioinfusion (cases) vs. conservative treatment without amnioinfusion (controls). | PMR: 4% vs. 18% in cases and controls, respectively (statistically significant). |
Das 2001 [154] | India. Prospective case control study. Women (N = 290); (N = 100 amnioinfusion group, N = 190 controls). | Compared the impact on perinatal mortality of amnioinfusion (intervention) vs. no amnioinfusion (controls). | PMR: 1/100 vs. 16/190 in amnioinfusion and control groups, respectively; P = 0.01. |
De Santis et al. 2003 [127] | Italy. Tertiary care center. Quasi-RCT. Women (N = 71) with pre-term premature rupture of membranes (pPROM) at <26 weeks of gestational age (N = 37 amnioinfusion group, N = 34 controls). | Compared the impact on fetal survival of serial transabdominal amnioinfusion with saline every 7 days in case of persistent oligohydramnios (intervention) vs. expectant management (controls). | Intrauterine fetal survival: 24/37 (64.8%) vs. 11/34 (32.3%) in intervention and control groups, respectively, p < 0.01. |
Halvax 2002 [155] | Hungary. Tertiary referral hospital (University of Pecs). Retrospective analysis. N = 228 women (N = 118 amnioinfusion group, N = 110 controls). | Compared the impact of simultaneous use of fetal pulse oximetry and amnioinfusion in meconium stained amniotic fluid (intervention) vs. no amnioinfusion (controls). All monitored with cardiotocography. | Meconium below the vocal cords: 0% vs. 10.1% in intervention and control groups, respectively; P < 0.01. Operative delivery rate: 22.0% vs. 30.9% in intervention and control groups, respectively; P < 0.05. |
Sahu 2003 [131] | India. Prospective case-control study. Women (N = 250) having meconium stained amniotic fluid during labour (N = 100 amnioinfusion group, N = 150 controls. | Compared the impact on perinatal mortality of amnioinfusion (study group) vs. no amnioinfusion (controls). | PMR: 1/100 (1%) vs. 12/150 (8%) in the study and control groups, respectively; P = 0.01. |
Amnioinfusion for PROM
Amnioinfusion for oligohydramnios with intact membranes
Prevention of meconium aspiration
New meta-analysis
Conclusion
Summary
Evidence of no or negative impact (leave out of programmes) | Uncertain evidence (need for additional research before including in programmes) | Some evidence (may include in programmes, but further evaluation is warranted) | Clear evidence (merits inclusion in programmes) | |
---|---|---|---|---|
Instrumental delivery (vacuum vs. forceps) | X (neither method superior, but either or both should be in programs) | |||
Comprehensive emergency obstetric care packages, including Caesarean section | X | |||
Induction of labour (vs. expectant management) | X (for post-term pregnancy only) | |||
Drugs for cervical ripening and induction of labour | X | |||
Planned Caesarean for breech presentation | X (attendant risks in low-resource settings with poor EOC access) | |||
Maternal hyperoxygenation for impaired fetal growth | X (some evidence but biodynamics poorly understood) | |||
Amnioinfusion | X | |||
Magnesium sulphate for pre-eclampsia/eclampsia and pre-term labour | X |
Implications for programmes
Research gaps
Biodynamics and descriptive studies
|
---|
• Frequency of uterine rupture in pregnancies subsequent to Caesarean section in rural settings |
• Dynamics of maternal hyperoxygenation in placental perfusion and feto-placental circulation (risk or benefit to fetus?) |
• Drug safety studies (fetal/neonatal outcomes): magnesium sulphate |
• Safety of misoprostol for induction of labour |
◦ Vaginal misoprostol optimal dosing and dose-range studies |
Pilot/clinical/cohort studies of interventions
|
• Trials/comparisons of lesser-studied induction methods |
◦ Extra-amniotic prostaglandins |
◦ IV prostaglandins |
• Feasibility and effectiveness of oral misoprostol administration in low-resource settings |
• Foley catheter insertion for pre-induction cervical ripening |
• Transabdominal amnioinfusion, especially in cases of intact membranes |
• Effective interventions for pre-term labour |
• Acceptability and utility of inexpensive manual vacuum extractors compared to forceps for assisted vaginal delivery |
Rigorously designed large RCTs powered to detect impact on stillbirth
|
• Induction vs. expectant management for macrosomia and mild pre-eclampsia |
• Comparison of first attempting assisted vaginal delivery in operating theatre vs. immediate Caesarean for obstructed labour in low-/middle-income countries |
• Distress-to-decision-to-incision studies for Caesarean in low-/middle-income country settings |
• Planned Caesarean vs. vaginal breech trials to confirm or refute recommendation of Term Breech Trial for routine policy of planned Caesarean for breech |
• Impact of hyperoxygenation on stillbirth rate |
• Impact of amnioinfusion on stillbirth rate |
Large effectiveness trials at scale or population level
|
• Unmet obstetric need studies reporting stillbirth outcomes (in addition to maternal impact) |
• Association of facility quality improvement in comprehensive EOC/EmOC services with perinatal outcomes |