Trial from ANZCTR


Trial ID ACTRN12609000349246
Trial Status: Registered
Date Submitted: 18/12/2008
Date Registered: 25/05/2009
Retrospectively registered

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Public title A randomised controlled trial of caseload midwifery care
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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Secondary ID [1] 282070 0
nil known
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UTN
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Trial acronym M@NGO: Midwives at New Group practice Options
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Health condition(s) or problem(s) studied:
the reorganisation of midwifery care 4142 0
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Care during childbirth 4291 0
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Condition category: Condition code:
Reproductive Health and Childbirth Normal pregnancy
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4345 4345 0 0
Reproductive Health and Childbirth Childbirth and postnatal care
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4519 4519 0 0
Reproductive Health and Childbirth Other reproductive health and childbirth disorders
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4521 4521 0 0

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Descriptions 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.
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Intervention Code:
Treatment: Other 4021 0
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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.
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Control group Active
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Primary Outcome: the proportion of women having an unassisted vaginal birth 5224 0
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Timepoint: assessed by participants hospital record on a weekly basis during the study 5224 0
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Primary Outcome: The proportion of instrumental vaginal births 5400 0
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Timepoint: assessed by participants hospital record on a weekly basis during the study 5400 0
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Primary Outcome: the proportion of women having a
caesarean section birth.
5402 0
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Timepoint: assessed by participants hospital record on a weekly basis during the study 5402 0
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Secondary Outcome: the proportion of women having perineal trauma 8807 0
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Timepoint: assessed by participants hospital record on a weekly basis during the study 8807 0
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Secondary Outcome: the proportion of women having Obstetric analgesia 9073 0
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Timepoint: assessed by participants hospital record on a weekly basis during the study 9073 0
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Secondary Outcome: the proportion of women having Induction of labour and augmentation of labour 9076 0
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Timepoint: assessed by participants hospital record on a weekly basis during the study 9076 0
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Secondary Outcome: Satisfaction with care 9077 0
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Timepoint: a questionnaire offered at six weeks post partum 9077 0
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Secondary Outcome: Staff attrition and satisfaction 9078 0
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Timepoint: a questionnaire offered at 12 months from the beginning of the trial 9078 0
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Secondary Outcome: rates of neonatal morbidity (including admission to the neonatal intensive care unit), 9079 0
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Timepoint: assessed by participants hospital record on a weekly basis during the study 9079 0
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Secondary Outcome: To determine whether caseload midwifery care costs the same as routine
maternity care.
9082 0
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Timepoint: 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 9082 0
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Key inclusion criteria Women will be eligible for trial entry if they are less than 24 completed weeks of pregnancy at booking in
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Minimum age 18 Years
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Maximum age No limit
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Gender Females
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Healthy volunteers? Yes
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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).
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 8/12/2008
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Date of first participant enrolment 8/12/2008
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 15/04/2011
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Target sample size 1950
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s) NSW,QLD
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Recruitment outside Australia

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Funding Source: Government body 4682 0
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Name: National Health and Medical Research Council of Australia (NHMRC) 4682 0
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Address: GPO Box 1421, Canberra ACT 2601
Level 5, 20 Allara street, Canberra City ACT
4682 0
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Country: Australia 4682 0
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Primary Sponsor University
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Name: The University of Sydney
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Address: Faculty of Nursing and Midwifery
Level 5, Building C (M02)
The University of Sydney
NSW 2006
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Country: Australia
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Secondary Sponsor: None 4229 0
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Name: 4229 0
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Address: 4229 0
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Country: 4229 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The University of Sydney Human Research Ethics Committee 6720 0
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Address: The University of Sydney
Level 6, Jane Foss Russell Building - G02
City Road - Darlington Campus
The University of Sydney NSW 2006
6720 0
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Country: Australia 6720 0
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Approval Date: 08/04/2008 6720 0
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Submitted Date: 01/02/2008 6720 0
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HREC: 6720 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Prof
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Name: Sally K Tracy
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Address: Midwifery and Women's Health Research Unit Level 1 Royal Hospital for Women Randwick 2031 NSW Australia
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Country: Australia
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Tel: +61 420277106
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Fax:
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Email: sally.tracy@sydney.edu.au
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Contact person for public queries
Title: Prof
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Name: Sally K Tracy
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Address: Midwifery Research Unit Level 1 Barker Street Royal Hospital for Women Randwick NSW 2031
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Country: Australia
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Tel: 61 2 9381 6740
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Fax: 61 2 93826736
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Email: sally.tracy@sydney.edu.au
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Contact person for scientific queries
Title: Prof
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Name: Sally K Tracy
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Address: Midwifery Research Unit Level 1 Barker Street Royal Hospital for Women, Randwick, NSW 2031
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Country: Australia
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Tel: 61 2 9381 6740
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Fax: 61 2 93826736
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Email: sally.tracy@sydney.edu.au
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Contact person responsible for updating information
Title: Prof
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Name: Sally K Tracy
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Address: Midwifery Research Unit Level 1 Barker Street Royal Hospital for Women Randwick NSW 2031
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Country: Australia
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Tel: 61 2 93826740
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Fax: 61 2 93826736
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Email: sally.tracy@sydney.edu.au
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Addition Cancer fields
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