Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000073404
Ethics application status
Approved
Date submitted
15/12/2006
Date registered
23/01/2007
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Caseload midwifery for women at low risk of medical complications: a randomised controlled trial
Scientific title
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
Secondary ID [1] 296626 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COSMOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternity model of care 1565 0
Caesarean section 310449 0
Condition category
Condition code
Reproductive Health and Childbirth 1666 1666 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 1510 0
Other interventions
Comparator / control treatment
For women allocated to standard care can choose from any other care option at the particular trial site.
Control group
Active

Outcomes
Primary outcome [1] 2306 0
To determine whether caseload (one on one) midwifery care for women at low risk of medical complications decreases the proportion of women having a caesarean section birth, compared with women in ‘standard’ care models (19 compared with 14%).
Timepoint [1] 2306 0
Measured at time of birth, obtained from medical record as soon as practical.
Secondary outcome [1] 4019 0
To test if women receiving caseload care have: decreased rates of instrumental vaginal births, obstetric analgesia, perineal trauma and induction of labour (measures from birth record).
Timepoint [1] 4019 0
no update
Secondary outcome [2] 4020 0
Decreased postnatal depression
Timepoint [2] 4020 0
6 weeks and 6 months
Secondary outcome [3] 4021 0
Increased satisfaction with care
Timepoint [3] 4021 0
6 months
Secondary outcome [4] 4022 0
A higher proportion of breastfeeding
Timepoint [4] 4022 0
At 6 weeks and 6 months
Secondary outcome [5] 4023 0
Decreased smoking
Timepoint [5] 4023 0
Obtained from pregnancy record and also at 6 weeks postpartum.
Secondary outcome [6] 4024 0
To test if the model is cost neutral and/or cost effective
Timepoint [6] 4024 0
Measured at a variety of time points depending on what is measured as well as resource use data collected at 6 weeks and 6 months postpartum.
Secondary outcome [7] 4025 0
To test if midwives providing caseload care have decreased staff attrition and increased work satisfaction.
Timepoint [7] 4025 0
Measured early in trial, approximatley one month after a midwife commences work in the model, and at completion of intervention or when a midwife leaves the model.
Secondary outcome [8] 4026 0
Other outcomes collected will include measures of perinatal and maternal morbidity and mortality.
Timepoint [8] 4026 0
From pregnancy and birth record and at 6 weeks and 6 months postpartum.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification for site and parity. Dynamic (adaptive) randomisation method
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
11/04/2007
Date of last participant enrolment
Anticipated
Actual
8/06/2010
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
2008
Accrual to date
Final
2314
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1811 0
Government body
Name [1] 1811 0
National Health and Medical Research Council project grant
Country [1] 1811 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
NHMRC
16 Marcus Clarke St
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 1633 0
None
Name [1] 1633 0
Nil
Address [1] 1633 0
Country [1] 1633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3396 0
Ethics committee address [1] 3396 0
Ethics committee country [1] 3396 0
Australia
Date submitted for ethics approval [1] 3396 0
27/03/2007
Approval date [1] 3396 0
09/04/2007
Ethics approval number [1] 3396 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27444 0
Prof Helen McLachlan
Address 27444 0
La Trobe University
Bundoora, VIC, 3086
Country 27444 0
Australia
Phone 27444 0
001161394795955
Fax 27444 0
Email 27444 0
[email protected]
Contact person for public queries
Name 10699 0
Helen McLachlan
Address 10699 0
La Trobe University
Bundoora, VIC, 3086
Country 10699 0
Australia
Phone 10699 0
+61 3 83418500
Fax 10699 0
+61 3 83418555
Email 10699 0
[email protected]
Contact person for scientific queries
Name 1627 0
Helen McLachlan
Address 1627 0
Judith Lumley Centre
La Trobe University
Bundoora, VIC, 3086
Country 1627 0
Australia
Phone 1627 0
61 3 94795955
Fax 1627 0
+61 3 83418555
Email 1627 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.