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Trial registered on ANZCTR


Registration number
ACTRN12622000607774
Ethics application status
Approved
Date submitted
28/03/2022
Date registered
22/04/2022
Date last updated
5/04/2024
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the impact of midwife-led group antenatal care on caesarean section rates and infant health: a multi-site randomised controlled trial
Scientific title
Exploring the impact of midwife-led group antenatal care for primiparous women on caesarean section rates and infant health: a multi-site randomised controlled trial
Secondary ID [1] 306652 0
MRFF2007108
Universal Trial Number (UTN)
Trial acronym
GEM Care (Group Education and Midwifery Care)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caesarean section 325582 0
Premature birth 325583 0
Low birth weight 325841 0
Stillbirth 325954 0
Gestational weight gain 325955 0
Condition category
Condition code
Reproductive Health and Childbirth 322950 322950 0 0
Antenatal care
Reproductive Health and Childbirth 323265 323265 0 0
Breast feeding
Reproductive Health and Childbirth 323266 323266 0 0
Complications of newborn
Reproductive Health and Childbirth 323267 323267 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Pregnancy care in 'Group Care' - Midwife-led group antenatal care and education (Group Care) integrates antenatal care, childbirth preparation, and early parenting education into group sessions that occur at regular intervals throughout pregnancy, facilitated by two midwives who remain with the group. It includes continuity of midwife carer; increased education and information sharing about childbirth, breastfeeding and early parenting; and peer support. The aim is to help women to choose health-promoting behaviours, and be active participants in their care.

Clinical care for women in both groups will be as per the clinical guidelines in operation at the respective study site. All women will have access to support services normally available to them, and medical input as appropriate.

Women allocated to 'Group Care' will receive all their antenatal care in small groups of 10 to 12 women of a similar gestation. Women will be offered a choice of group times and locations based on their due date, with each group including women due in the same 2 to 3 week period to maximise peer support potential, and optimise timing of education and discussions. The group-based approach enables pre-set appointment schedules, with no waiting time for pregnancy visits. Group session dates and times are booked for a woman’s entire pregnancy. Groups meet for two hours six times in pregnancy at the standard pregnancy appointment gestations. Each group is run by the same two midwives every session, to provide continuity and to allow flexibility with information provision over the course of any particular group, so timing of information/discussions can be altered to suit group needs. Physical assessments e.g. fundal height and fetal heart rate take place individually, in the group space, but in a private screened area to maintain privacy. Physical assessments are completed during the session in the private area while the group is ongoing. All sessions include routine clinical care and assessment, along with childbirth education, preparation for parenting, and peer support.

Timing of 'Group Care' appointments, summary of content and appointment duration.
26 weeks gestation: Introductions/group formation goals/care plans, pregnancy issues, breastfeeding, expectations (2 hours)
30 weeks gestation: Normal newborn behaviour, breastfeeding, labour and birth, feelings, expectations, worries, concerns (2 hours)
33 weeks gestation: Labour and birth, postnatal care, breastfeeding, parenting ((2 hours plus, 2 hour hospital tour)
36 weeks gestation: Preparing for home, community supports, Group B Streptococcus testing, complications, concerns (2 hours)
38 weeks gestation: Early postnatal care, labour and birth, expectations, worries (2 hours)
40 weeks gestation: Labour, birth, induction, breastfeeding (2 hours)

Physical and online information materials provided will be those given during standard pregnancy care (hospital developed, reviewed and promoted materials).
Emphasis is placed on engaging women in their own health care and empowering them to be proactive. Women can bring a partner or support person, with some groups available for women-only for those who prefer. Women in Group Care who need additional obstetric or other care during pregnancy will remain in the group, with additional care as required. Women at higher risk initially will have concurrent collaborative medical care as is usual practice in midwife-led models at the study sites.

Adherence of participants to sessions will be monitored using hospital data (e.g. checked into appointment, Did Not Attend etc.).
Observations of sessions will be conducted ad hoc by research team as required but as it is woman-led and proactive there may be deviations from the planned content schedule to address the groups individual needs, as decided by the groups.
Intervention code [1] 323092 0
Prevention
Intervention code [2] 323094 0
Behaviour
Comparator / control treatment
'Usual care' - pregnancy care provided individually by standard models of care already provided by the study sites.

Women randomised to usual care will have access to all the standard care options at the site, e.g. hospital-based midwife, caseload or team care, or shared care with a GP or midwife. All these models provide individual care (vs the group-based approach being tested), with varying levels of continuity, and differing flexibility of care location and time.
Control group
Active

Outcomes
Primary outcome [1] 330723 0
Proportion of women giving birth by caesarean section assessed by accessing patient electronic or paper medical records
Timepoint [1] 330723 0
At birth
Secondary outcome [1] 407307 0
Proportion of women who gave birth to 'healthy' infants' (defined as being born alive, >=37 weeks, at >= 2500g, and not admitted to neonatal intensive care unit) assessed by accessing electronic or hospital records
Timepoint [1] 407307 0
At birth
Secondary outcome [2] 407475 0
Gestational weight gain – we will measure the percentage of women whose gestational weight changes are within Institute of Medicine (IOM) guidelines by asking them pre pregnancy weight (in recruitment survey based on memory) and weight at recruitment (by electronic standing scales), and at 36 weeks in the online survey (ask women to weigh themselves)
Timepoint [2] 407475 0
Pre pregnancy weight asked at recruitment, weight at recruitment (approx 16-24 weeks) and at 36 weeks
Secondary outcome [3] 407476 0
Breastfeeding intention asked at recruitment (in recruitment survey)
Timepoint [3] 407476 0
At recruitment (approx 16-24 weeks)
Secondary outcome [4] 407477 0
Breastfeeding initiation
Timepoint [4] 407477 0
Initiation data from medical record after birth
Secondary outcome [5] 407479 0
Maintenance of breastfeeding
Timepoint [5] 407479 0
Asking at three month survey post birth if any breast milk feeding using questions specifically designed for this study
Secondary outcome [6] 407480 0
Satisfaction with care measured by a 7-point likert-type scale used extensively by the team previously, with a global question “Overall, how would you describe your care during pregnancy” where ‘1’ is ‘Very poor’ and ‘7’ is ‘Very good’
Timepoint [6] 407480 0
Measured at 3 month post birth telephone interview
Secondary outcome [7] 407481 0
Perceived social support, measured using the MOS Social Support Survey and using one social support question designed for the study
Timepoint [7] 407481 0
Measured at recruitment using single social support question, measured at 36 weeks gestation and three months post birth using MOS Social Support Survey
Secondary outcome [8] 407482 0
Healthy behaviours, e.g. smoking, alcohol, exercise, by self-report using study-specific questionnaire
Timepoint [8] 407482 0
Measured at recruitment, 36 weeks gestation and three months post birth
Secondary outcome [9] 407483 0
Anxiety symptoms, using the DASS-21 (anxiety scale)
Timepoint [9] 407483 0
Measured at 36 weeks gestation and three months post birth
Secondary outcome [10] 407484 0
Parenting self-efficacy and readiness - LSAC scale
Timepoint [10] 407484 0
Measured at 36 weeks gestation
Secondary outcome [11] 407485 0
Quality of Life (AQol-8D)
Timepoint [11] 407485 0
Measured at recruitment, 36 weeks and three months post birth
Secondary outcome [12] 407486 0
Economics. Health service use since birth, and cost effectiveness measured by self-reported health service use using study-specific questionnaire
Timepoint [12] 407486 0
Measured three months post birth
Secondary outcome [13] 408469 0
Fear of childbirth, using the Fear of Childbirth Scale
Timepoint [13] 408469 0
Measured at recruitment and 36 weeks gestation

Eligibility
Key inclusion criteria
Primiparous women with a singleton pregnancy attending a study site as a public patient, assessed as low or moderate obstetric risk, less than 22 weeks’ gestation, and able to speak and understand English.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
At initial pregnancy booking visit women who are considered high risk needing close obstetric monitoring, drug and alcohol issues requiring specialist care, known major fetal anomaly or compromise requiring significant medical input (e.g. aneuploidy, heart defects), and women unable to provide informed consent.

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)
A secure, password-protected, computerised randomisation schedule will be designed and administered by an independent service, accessed via the telephone by recruiting staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be randomly allocated to the intervention (Group Care) or control group (usual care), with stratification by a) site, and b) risk status (low or moderate obstetric risk assessment). The randomisation ratio will be 5: 4 (i.e. 1.25:1) Group Care to usual care (taking into account the inflated sample size of the intervention arm only to account for potential clustering, and ensuring block sizes are divisible by the allocation ratio with permuted blocks of variable length between 9 and 18.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: In Australia 37% of primiparous women gave birth by CS in 2018. At the Women’s, in 2019/20 the CS rate for primiparous women was ˜36%, and at the Northern 35.6% (internal data). Considering that different models of care have different CS rates, e.g. team and caseload midwifery models have lower CS rates, but that women of high risk will be excluded, we estimate a baseline CS rate of 33% for women allocated to usual care. To detect a 5% decrease in CS to 28%, the smallest change we would consider clinically meaningful, and of adequate benefit to convince policy makers and care providers, with 80% power and a two-tailed alpha of 0.05, a sample of 2,740 women is required (1370 per arm). We will have near complete ascertainment of the primary outcome based on our previous work, but need to consider the potential clustering effect of group in the Group Care arm, so have inflated the sample size in that arm. We have estimated an intra-cluster correlation (ICC) of 0.026, based on our pilot study. The variance inflation factor (IF =1+(m-1)*ICC [where m = average cluster size]) was calculated as 1.234 (1+(10-1)*0.026). Thus, the required sample size in the Group Care arm is 1691(1370*1.234). Together with the 1370 women in the usual care arm, this leads to a final sample size of 3061 women. This will also give us 92% power to detect a 5% difference in the main secondary outcome (the ‘healthy infant’ composite), assuming a baseline rate 83% (study site data 2019) and an ICC of 0.07 (pilot data).
Planned analyses: Data will be collected to meet CONSORT guidelines. We will check the baseline comparability of the groups, then the intervention group will be compared with the control group for all trial hypotheses using intention-to-treat analysis. The proportion of women giving birth by CS will be compared for the primary outcome. Relative risks and 95% confidence intervals will be estimated using log-binomial regression with cluster-robust standard errors, adjusting for all stratification variables, and for any differences in the key demographic characteristics at baseline. For other outcomes, comparison of means will be undertaken using t-tests where data are normally distributed, or medians compared using Mann-Whitney U tests otherwise, with linear regression and quantile regression for comparison of means and medians respectively to account for clustering. A within trial cost-effectiveness analysis will be conducted. This will present the incremental costs of the intervention (costs of the intervention and health service use over the period of follow-up, minus costs accrued in the control arm) per caesarean section avoided. Differences in maternal quality of life will also be assessed. Future costs and benefits will be discounted at 5%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
2/01/2024
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
3061
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21947 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 21948 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 37040 0
3052 - Parkville
Recruitment postcode(s) [2] 37041 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 310979 0
Government body
Name [1] 310979 0
National Health and Medical Research Coucil
Country [1] 310979 0
Australia
Primary sponsor type
Individual
Name
Della Forster
Address
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country
Australia
Secondary sponsor category [1] 312287 0
None
Name [1] 312287 0
Address [1] 312287 0
Country [1] 312287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310534 0
The Royal Children's Hospital
Ethics committee address [1] 310534 0
50 Flemington Road
Parkville, Victoria 3052
Ethics committee country [1] 310534 0
Australia
Date submitted for ethics approval [1] 310534 0
01/08/2022
Approval date [1] 310534 0
18/04/2023
Ethics approval number [1] 310534 0
HREC/94351/RCHM-2023

Summary
Brief summary
Pregnancy and birth provide a critical window for intervening to improve short- and long-term health and wellbeing for women and their children, yet there is a lack of evidence to guide preventative interventions. At two sites in Victoria, Australia we will conduct a randomised controlled trial comparing midwife-led, group-based pregnancy care model with usual pregnancy care. We will implement and evaluate a midwife-led, group-based pregnancy care model aimed at influencing risk factors and behaviours that result in adverse outcomes in pregnancy and beyond. We aim to decrease the proportion of births by caesarean section, and the proportion of infants born premature or low birthweight. All three are associated with significant maternal and neonatal morbidity. This collaborative model combines continuity of midwife care, education and peer support to address women’s individual needs, support them to make informed decisions to achieve a healthy pregnancy, and improve clinical and psychosocial outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117990 0
Prof Della Forster
Address 117990 0
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country 117990 0
Australia
Phone 117990 0
+61 3 9479 8783
Fax 117990 0
Email 117990 0
D.Forster@latrobe.edu.au
Contact person for public queries
Name 117991 0
Ms Robyn Matthews
Address 117991 0
The Royal Women’s Hospital
Locked Bag 300
Grattan St and Flemington Rd
Parkville VIC 3052
Country 117991 0
Australia
Phone 117991 0
+61 3 8345 2932
Fax 117991 0
Email 117991 0
R.Matthews@latrobe.edu.au
Contact person for scientific queries
Name 117992 0
Dr Touran Shafiei
Address 117992 0
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country 117992 0
Australia
Phone 117992 0
+61 3 94798798
Fax 117992 0
Email 117992 0
t.shafiei@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published data only. Data will only be available post completion of trial and by individual request with appropriate research questions and ethics permission
When will data be available (start and end dates)?
Post completion of trial. No end date planned.
Available to whom?
Only those with appropriate research questions and ethics permission
Available for what types of analyses?
To be discussed with Professor Della Forster when request is made
How or where can data be obtained?
By request of Principle investigator Professor Della Forster (email: d.forster@latrobe.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15423Study protocol    Citation will be provided when protocol paper is p... [More Details]



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