Abstract
BackgroundIn Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6–12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail.Methods/designA two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self administered survey) and at 2 and 6 months postpartum by postal survey. Medical/obstetric outcomes will be abstracted from the medical record. The sample size of 2008 was calculated to identify a decrease in caesarean birth from 19 to 14% and detect a range of other significant clinical differences. Comprehensive process and economic evaluations will be conducted.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN012607000073404.
Highlights
In Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section
Many hospitals have responded by introducing caseload midwifery, a one to one midwifery model of care in which women are cared for by a primary midwife throughout pregnancy, birth and the early postnatal period; a model of care that has been subjected to very little rigorous evaluation
We know of only two randomised controlled trials (RCTs) of caseload midwifery care; both conducted in the United Kingdom in the1990s [2,3]
Summary
There is evidence from RCTs that continuity of midwifery care may lead to reduced caesarean sections [7,8] and instrumental vaginal births [9], and a decrease in other interventions during labour including induction [3,9] augmentation [9] analgesia use [9] and episiotomy [10,11]. There is a lack of evidence regarding the safety and the efficacy of the caseload model, the existing RCTs of midwifery care (mostly team midwifery) do report decreases in interventions in labour and birth. We plan to implement a caseload midwifery model under RCT conditions to evaluate its effect on the rate of caesarean section and on a range of significant secondary outcomes. Comprehensive process evaluation will be undertaken to explore sustainability issues and to assess intervention compliance
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