Trial registered on ANZCTR


Trial ID
ACTRN12609000349246
Ethics application status
Approved
Date submitted
18/12/2008
Date registered
25/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of caseload midwifery care
Scientific title
A randomised controlled trial to determine the difference between caseload midwifery care and routine care for women during pregnancy, labour and birth and postnatally measured by rate of interventions, maternal satisfaction and neonatal and maternal morbidity and cost.
Secondary ID [1] 282070 0
nil known
Universal Trial Number (UTN)
Trial acronym
M@NGO: Midwives at New Group practice Options
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the reorganisation of midwifery care 4142 0
Care during childbirth 4291 0
Condition category
Condition code
Reproductive Health and Childbirth 4345 4345 0 0
Normal pregnancy
Reproductive Health and Childbirth 4519 4519 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 4521 4521 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Caseload midwifery care:
Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a primary caseload midwife with one or two antenatal visits to be conducted by a ‘backup’ midwife. Caseload midwives work in group practices of four full time midwives each working a cycle of 152 hours during each four week period. The primary midwife is on call for the woman’s labour and birth except in designated circumstances such as annual leave; sick leave; having more than one woman in labour; or if it is on one of the two days per week that the primary midwife is scheduled to not work or be on call. Care will then be provided by a back-up midwife. The primary midwife will collaborate with obstetricians and other health professionals as necessary, and will continue to provide caseload care in addition to care provided by obstetricians if complications develop. In addition to providing care until after the birth of the baby, the primary midwife (or a back up midwife) will attend the hospital on most days to provide some postnatal care and will provide domiciliary care following discharge from hospital. Care will be provided according to hospital guidelines and protocols for up to six weeks following birth.
Intervention code [1] 4021 0
Treatment: Other
Comparator / control treatment
Standard or routine maternity care:
Women allocated to the control group can choose from the standard hospital options for care which include midwives clinic antenatally; GP shared care antnatally; followed by general public hospital care in labour and in the postnatal ward. This may involve women seeing a different midwife for every visit; care by junior medical obstetric staff; or shared care with an accredited general medical practitioner (GP) (i.e. the GP provides the majority of the woman’s antenatal care, usually nearer to her home, but the woman is booked for labour, birth and postnatal care at the hospital). Women may see an obstetrician during pregnancy with other referrals or consultation as necessary. When women come into the hospital for labour,
birth and postnatal care they will be cared for by whichever midwives and doctors are rostered for duty. Care will be provided according to the same hospital guidelines and protocols as for the women in the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 5224 0
the proportion of women having an unassisted vaginal birth
Timepoint [1] 5224 0
assessed by participants hospital record on a weekly basis during the study
Primary outcome [2] 5400 0
The proportion of instrumental vaginal births
Timepoint [2] 5400 0
assessed by participants hospital record on a weekly basis during the study
Primary outcome [3] 5402 0
the proportion of women having a
caesarean section birth.
Timepoint [3] 5402 0
assessed by participants hospital record on a weekly basis during the study
Secondary outcome [1] 8807 0
the proportion of women having perineal trauma
Timepoint [1] 8807 0
assessed by participants hospital record on a weekly basis during the study
Secondary outcome [2] 9073 0
the proportion of women having Obstetric analgesia
Timepoint [2] 9073 0
assessed by participants hospital record on a weekly basis during the study
Secondary outcome [3] 9076 0
the proportion of women having Induction of labour and augmentation of labour
Timepoint [3] 9076 0
assessed by participants hospital record on a weekly basis during the study
Secondary outcome [4] 9077 0
Satisfaction with care
Timepoint [4] 9077 0
a questionnaire offered at six weeks post partum
Secondary outcome [5] 9078 0
Staff attrition and satisfaction
Timepoint [5] 9078 0
a questionnaire offered at 12 months from the beginning of the trial
Secondary outcome [6] 9079 0
rates of neonatal morbidity (including admission to the neonatal intensive care unit),
Timepoint [6] 9079 0
assessed by participants hospital record on a weekly basis during the study
Secondary outcome [7] 9082 0
To determine whether caseload midwifery care costs the same as routine
maternity care.
Timepoint [7] 9082 0
Costs incurred against the public hospital system will be measured using hospital in-patient data in addition to the Birthrate Plus data being collected on staff activity. The cost of the full episode of pregnancy, labour, birth and postnatal care will be costed including readmission of mother and /or baby up to six weeks postnatally. childbirth episode

Eligibility
Key inclusion criteria
Women will be eligible for trial entry if they are less than 24 completed weeks of pregnancy at booking in
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women will be excluded from the trial if they 18 years or younger and are electively booked to give birth via caesarean section at the time of booking in; or are already booked with a named care provider at the time of booking (Obstetrician/GP/midwife).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will attend the hospital antenatal clinic affiliated with the hospital for their booking visit. At the first visit (booking clinic) women will be seen by a research midwife who ascertains if the woman has previously received written information and if so, she will be invited to participate. Following written consent, the midwife will randomise the woman to caseload midwifery care with a named midwife or routine care via a central telephone randomisation service authorised by the National Health and Medical Research Council (NHMRC) method; and enter details on the Trial Register and Daily Log Book.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central telephone randomisation service via the National Health and Medical Research Council (NHMRC) method.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy

Recruitment
Anticipated date of first participant enrolment
8/12/2008
Actual date of first participant enrolment
8/12/2008
Anticipated date last participant enrolled
Actual date last participant enrolled
15/04/2011
Anticipated date of last data collection
Actual date of last data collection
Target sample size
1950
Actual sample size
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 4682 0
Government body
Name [1] 4682 0
National Health and Medical Research Council of Australia (NHMRC)
Address [1] 4682 0
GPO Box 1421, Canberra ACT 2601
Level 5, 20 Allara street, Canberra City ACT
Country [1] 4682 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Nursing and Midwifery
Level 5, Building C (M02)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 4229 0
None
Name [1] 4229 0
Address [1] 4229 0
Country [1] 4229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6720 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 6720 0
The University of Sydney
Level 6, Jane Foss Russell Building - G02
City Road - Darlington Campus
The University of Sydney NSW 2006
Ethics committee country [1] 6720 0
Australia
Date submitted for ethics approval [1] 6720 0
01/02/2008
Approval date [1] 6720 0
08/04/2008
Ethics approval number [1] 6720 0

Summary
Brief summary
Restructuring maternity services to introduce caseload midwifery care involves radical changes to the organisation of conventional or routine midwifery and obstetric practices. All these changes make an impact on health planning and the allocation of finite resources. Many innovations are introduced in a relative policy vacuum. Models of maternity care are no exception. In addition to evidence on the experiences of women receiving caseload midwifery care and the experiences of obstetricians and midwives offering caseload care, the outcomes of the proposed trial will contribute:
1. Level 1 evidence of the safety and effectiveness of having a known caseload midwife for the continuum of pregnancy birth and postnatally.
2. Level 1 evidence of the safety and effectiveness of caseload midwifery care for women of all risk.
3. Level 1 evidence on the cost effectiveness of caseload midwifery care and routine obstetric care for all women.
4. ‘Australian randomised controlled trial data to the Cochrane systematic review of midwife led care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35048 0
Prof Sally K Tracy
Address 35048 0
Midwifery and Women's Health Research Unit
Level 1 Royal Hospital for Women
Randwick 2031
NSW
Australia
Country 35048 0
Australia
Phone 35048 0
+61 420277106
Fax 35048 0
Email 35048 0
sally.tracy@sydney.edu.au
Contact person for public queries
Name 12395 0
Prof Sally K Tracy
Address 12395 0
Midwifery Research Unit
Level 1 Barker Street
Royal Hospital for Women
Randwick NSW 2031
Country 12395 0
Australia
Phone 12395 0
61 2 9381 6740
Fax 12395 0
61 2 93826736
Email 12395 0
sally.tracy@sydney.edu.au
Contact person for scientific queries
Name 3323 0
Prof Sally K Tracy
Address 3323 0
Midwifery Research Unit
Level 1 Barker Street
Royal Hospital for Women,
Randwick, NSW 2031
Country 3323 0
Australia
Phone 3323 0
61 2 9381 6740
Fax 3323 0
61 2 93826736
Email 3323 0
sally.tracy@sydney.edu.au