Begley 2009.
Methods | Randomized controlled trial. Eligibile and consenting women were randomized at the time of booking for antenatal care. | |
Participants | 1653 nulliparous and multiparous women (randomized in a 2:1 ratio ‐‐ 1102 in the midwifery‐led care group and 551 to consultant‐led care), booked for delivery at 2 hospitals in Ireland. Participants were < 24 weeks' gestation, judged to be low in obstetrical risk, aged 16‐40 years, with singleton pregnancies. | |
Interventions | Midwifery‐led care: shared antenatal care between midwives and family doctors. Intrapartum care by midwives, who (whenever possible) remained with women who were transferred to consultant‐led care in the standard labour ward. Antenatal and intrapartum care were provided in a refurbished unit with a separate entrance, adjacent to the conventional labour ward. The unit contained two birthing rooms with home‐like decor and a birthing pool. Medical equipment was concealed from view. Consultant‐led care: the organization and delivery of care, from initial booking through the postnatal period, was led by a consultant‐obstetrician, within either a public or private system of maternity care. General practitioners may also have been involved in antenatal care. Intrapartum care was provided by midwives, but consultants may have been present for the birth. No details about the conventional hospital labour wards were provided. |
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Outcomes | 10 primary outcomes: induction of labour, continuous electronic fetal monitoring, augmentation of labour, episiotomy, caesarean birth, instrumental birth, postpartum hemorrhage, Apgar score < 7, initiation of breastfeeding; and umbilical cord pH. An extensive list of secondary outcomes (n > 60) included serious maternal and perinatal morbidity and mortality, healthcare costs, and medical interventions during pregnancy, childbirth, and the postnatal period. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerized random number generator. |
Allocation concealment (selection bias) | Low risk | Central telephone randomization service. |
Blinding (performance bias and detection bias) All outcomes | High risk | Neither women nor care providers could be blinded. Data collectors were unblinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record data were available for all but 9 of the1653 who were randomized. Usable postpartum questionnaire data was only obtained for 22% of those originally randomized. |
Selective reporting (reporting bias) | High risk | Pre‐specified neonatal outcomes included hypoxic ischemic encephalopathy, neonatal seizures, meconium aspiration, serious neonatal trauma but no outcome data were provided. Results were listed for all study outcomes. |
Other bias | Low risk | No other potential sources of bias were noted. |