A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options).
BACKGROUND
Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant.Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice.) We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial.


METHODS
A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs.


CONCLUSIONS
Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05) to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive care of all neonates from 9.9% to 5.8% (requires 721 in each arm). The study is not powered to detect infant or maternal mortality, however all deaths will be reported. Other significant findings will be reported, including a comprehensive process and economic evaluation.


BACKGROUND
Australian New Zealand Clinical Trials Registry ACTRN12609000349246.
Midwifery and Women's Health Research Unit, Royal Hospital for Women, Barker Street, Randwick, New South Wales, 2031. sally.tracy@sydney.edu.au
Sally K
SK
Tracy
Donna
D
Hartz
Bev
B
Hall
Jyai
J
Allen
Amanda
A
Forti
Anne
A
Lainchbury
Jan
J
White
Alec
A
Welsh
Mark
M
Tracy
Sue
S
Kildea
D001315:Australia; D003695:Delivery of Health Care; D005260:Female; D006123:Group Practice; D006801:Humans; D007231:Infant, Newborn; D008427:Maternal Health Services; D008880:Midwifery; D018579:Patient Selection; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control*; D011256:Pregnancy Outcome; D011795:Surveys and Questionnaires; D016526:Workload