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Caseload midwifery for women at low risk of medical complications: a randomised controlled trial

A randomised trial comparing One-to-One midwifery care with standard hospital maternity care for women at low risk, in order to decrease operative birth and other interventions and increase the duration of breastfeeding and women’s satisfaction with care, with no increase in costs of care

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000073404
Acronym
COSMOS
Enrollment
2314
Registered
2007-01-23
Start date
2007-04-11
Completion date
2010-06-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In Australia and internationally, there is concern about the growing proportion of women being delivered by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies, and decreased fertility; and significant resource implications. Randomised controlled trials (RCT) of continuity of midwifery care have reported reduced caesareans, and other interventions in labour. They have also found increased satisfaction, with no statistically significant differences in perinatal morbidity or mortality. One Australian RCT comparing continuity of care (team midwifery) with standard care demonstrated a decrease in women having caesarean birth from 18% to 13%. 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 care. We want to determine whether caseload (one on one) midwifery care decreases the proportion of women having a caesarean section birth, compared with women in ‘standard’ care models (for women at low risk of medical complications). We will also explore other outcomes such as rates of instrumental vaginal births, analgesia, perineal trauma and induction of labour; postnatal depression; satisfaction with care; the proportion breastfeeding at 6 weeks and 6 months; smoking; andthe cost of this model. A final area is about midwives: to explore how this model affects midwives.

Interventions

The intervention is caseload midwifery. Women allocated to the intervention will receive antenatal, intrapartum and postpartum care from a known midwife with one or two antenatal visits conducted by a ‘back-up’ midwife. The midwife will collaborate with obstetricians and other h

The intervention is caseload midwifery. Women allocated to the intervention will receive antenatal, intrapartum and postpartum care from a known midwife with one or two antenatal visits conducted by a ‘back-up’ midwife. The midwife 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. Each midwife will be allocated a group of women to care for in this way (a caseload). The intervention is from the pregnancy booking visit until 5 days after birth (approximately 6-7 months).

Sponsors

National Health and Medical Research Council
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Low-medical risk at recruitment;- English-speaking: able to speak, read and write in English;- Less than 24 completed weeks gestation at recruitment.- of childbearing age (on average 18-45 years, but women could be yournger or older than this providing all other eligibility criteria are met).

Exclusion criteria

High medical risk including (1) obstetric history such as stillbirth or neonatal death; three or more consecutive miscarriages; previous fetal death in utero, previous preterm birth (<32 weeks); previous mid-trimester loss/cervical incompetence/cone biopsy/known uterine anomaly; previous early onset of pre-eclampsia (<32 weeks); or rhesus iso-immunisation. (2) Complications during current pregnancy such as multiple pregnancy; or fetal abnormality detected. (3) Medical conditions such as cardiac disease; essential hypertension; renal disease; pre-existing diabetes; previous gestational diabetes; epilepsy; severe asthma; substance use; significant psychiatric disorders; obesity (>35BMI) or significantly underweight.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026