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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]

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

Caesarean section

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

Measured at time of birth, obtained from medical record as soon as practical.

Secondary outcome [1]

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]

no update

Secondary outcome [2]

Decreased postnatal depression

Timepoint [2]

6 weeks and 6 months

Secondary outcome [3]

Increased satisfaction with care

Timepoint [3]

6 months

Secondary outcome [4]

A higher proportion of breastfeeding

Timepoint [4]

At 6 weeks and 6 months

Secondary outcome [5]

Decreased smoking

Timepoint [5]

Obtained from pregnancy record and also at 6 weeks postpartum.

Secondary outcome [6]

To test if the model is cost neutral and/or cost effective

Timepoint [6]

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]

To test if midwives providing caseload care have decreased staff attrition and increased work satisfaction.

Timepoint [7]

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]

Other outcomes collected will include measures of perinatal and maternal morbidity and mortality.

Timepoint [8]

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?

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]

Government body

Name [1]

National Health and Medical Research Council project grant

Address [1]

NHMRC
16 Marcus Clarke St
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/03/2007

Approval date [1]

09/04/2007

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Peer reviewed publications:
McLachlan, H. L., et al. (2008) COSMOS: COmparing Standard Maternity care with one-to-one midwifery support: A randomised controlled trial. BMC Pregnancy and Childbirth 8,  DOI: 10.1186/1471-2393-8-35.

McLachlan, H., et al. (2008). "COSMOS: COmparing Standard Maternity care with One-to-one midwifery Support: a randomised controlled trial." BMC Pregnancy Childbirth 8.

Forster, D. A., et al. (2011) Exploring implementation and sustainability of models of care: can theory help? BMC Public Health 11, 10 

McLachlan, H. L., et al. (2012). "Effects of continuity of care by a primary midwife (caseload midwifery) on caesarean section rates in women of low obstetric risk: the COSMOS randomised controlled trial." BJOG: An International Journal of Obstetrics & Gynaecology 119(12): 1483–1492.

Davey, M.-A., et al. (2013). "Influence of timing of admission in labour and management of labour on method of birth: results from a randomised controlled trial of caseload midwifery (COSMOS trial)." Midwifery 29(12): 1297–1302.

Newton, M. S., et al. (2014) Comparing satisfaction and burnout between caseload and standard care midwives: Findings from two cross-sectional surveys conducted in Victoria, Australia. BMC Pregnancy and Childbirth 14,  DOI: 10.1186/s12884-014-0426-7

Forster, D. A., et al. (2014) Individualised, flexible postnatal care: a feasibility study for a randomised controlled trial. BMC Health Services Research 14,  DOI: 10.1186/s12913-014-0569-2

Dawson, K., et al. (2015). "Exploring midwifery students? views and experiences of caseload midwifery: A cross-sectional survey conducted in Victoria, Australia." Midwifery 31(2): e7-e15.

Forster, D. A., et al. (2016) Continuity of care by a primary midwife (caseload midwifery) increases women’s satisfaction with antenatal, intrapartum and postpartum care: results from the COSMOS randomised controlled trial. BMC Pregnancy and Childbirth 16,  DOI: 10.1186/s12884-016-0798-y

McLachlan, H. L., et al. (2016). "The effect of primary midwife-led care on women's experience of childbirth: results from the COSMOS randomised controlled trial." BJOG: An International Journal of Obstetrics & Gynaecology 123(3): 465-474.

Public notes

Contacts

Principal investigator

Name

Prof Helen McLachlan

Address

La Trobe University
Bundoora, VIC, 3086

Country

Australia

Phone

001161394795955

Fax

h.mclachlan@latrobe.edu.au

Contact person for public queries

Name

Helen McLachlan

Address

La Trobe University
Bundoora, VIC, 3086

Country

Australia

Phone

+61 3 83418500

Fax

+61 3 83418555

D.Forster@latrobe.edu.au

Contact person for scientific queries

Name

Helen McLachlan

Address

Judith Lumley Centre
La Trobe University
Bundoora, VIC, 3086

Country

Australia

Phone

61 3 94795955

Fax

+61 3 83418555

h.mclachlan@latrobe.edu.au

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.

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