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Trial registered on ANZCTR


Registration number
ACTRN12623000858695
Ethics application status
Approved
Date submitted
20/07/2023
Date registered
9/08/2023
Date last updated
9/08/2023
Date data sharing statement initially provided
9/08/2023
Date results provided
9/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the feasibility and acceptability of group antenatal care and education: a pilot randomised controlled trial
Scientific title
Exploring the feasibility and acceptability of group antenatal care and education for primigravid women: a pilot randomised controlled trial
Secondary ID [1] 310153 0
None
Universal Trial Number (UTN)
Trial acronym
GEM Care - pilot
Linked study record
This pilot feasibility study is the parent study to inform trial ACTRN12622000607774p

Health condition
Health condition(s) or problem(s) studied:
Caesarean section 330725 0
Condition category
Condition code
Reproductive Health and Childbirth 327567 327567 0 0
Antenatal care
Reproductive Health and Childbirth 327568 327568 0 0
Breast feeding
Reproductive Health and Childbirth 327569 327569 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 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 site.

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] 326549 0
Prevention
Intervention code [2] 326550 0
Behaviour
Comparator / control treatment
'Usual care' - pregnancy care provided individually by standard models of care already provided by the study site.

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] 335410 0
Assess for feasibility of a larger RCT trial by assessing uptake by women to the model within trial conditions (e.g., planned randomisation).
Uptake will be measured by women’s willingness to be randomised for a trial by collecting data during the recruitment period of number of eligible women, number of women who consented to be part of the study and reasons for declining to be part of the stud. Data will be measured by auditing study enrollment and withdrawals logs.
Timepoint [1] 335410 0
Three months post birth of last participant in pilot study
Primary outcome [2] 335626 0
Assess viability of the Group Care model by measure adherence to the planned schedule in the intervention arm. Adherence will be measured by what percentage of the visits in the intervention arm were conducted in the group model by accessing patient electronic or paper medical records
Timepoint [2] 335626 0
Three months post birth of last participant
Secondary outcome [1] 424417 0
Investigate women’s satisfaction with their care (including what they did and did not like about Group Care and how it could be improved) using specifically designed questions for this study
Timepoint [1] 424417 0
Assessed six weeks post birth of baby at telephone based survey
Secondary outcome [2] 424418 0
Explore clinicians’ views of Group Care using a focus group with eight midwives who worked in the Group Care model using semi-structured questions that is facilitated by two members of the research team
Timepoint [2] 424418 0
Three months post final birth in pilot study
Secondary outcome [3] 424444 0
Explore if there is any obvious evidence of harm in providing Group Care for pregnancy care by reviewing adverse events associated (e.g., stillbirth, premature birth, fetal growth reduction etc.) determined by accessing patient electronic or paper medical records
Timepoint [3] 424444 0
Measured at birth

Eligibility
Key inclusion criteria
English-speaking primigravid women with a singleton uncomplicated pregnancy who met the hospital’s clinical guidelines as low obstetric risk at the time of the booking visit (i.e., eligible for midwife-led care) and who were less or equal to 24 weeks pregnant at recruitment were eligible.
Minimum age
19 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women were ineligible if (at the booking visit) they had a high level of social risk or vulnerability (needing specialised one-to-one support in pregnancy), had drug and alcohol issues that required specialist care, were experiencing significant mental health issues, or were 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 researcher not directly involved in the analysis of the study results or recruitment of participants will prepare the randomisation schedule using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher generated a random allocation sequence for each of the proposed groups. Women will be randomised by unbalanced block randomisation. The randomisation ratio will be 1:1 (i.e. approximately same number of women in each trial arm) each arm of the study.
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
Safety
Statistical methods / analysis
This was a pilot whose main aim was to explore if it was possible to develop and implement the Group Care model at the study site, if women would take it up, and if so, if they would be willing to be randomised. We therefore did not do power calculations based on a clinical outcome. Instead, we based our sample size on recruiting enough women to assess feasibility. We estimated that running four groups of 10 women would be adequate to ascertain RCT potential uptake, as well as look at limited clinical outcome data to check for any obvious potential harm resulting from participating.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/05/2017
Date of last participant enrolment
Anticipated
Actual
22/06/2017
Date of last data collection
Anticipated
Actual
20/02/2018
Sample size
Target
80
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25212 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 40883 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 314313 0
Hospital
Name [1] 314313 0
The Royal Women's Hospital
Country [1] 314313 0
Australia
Primary sponsor type
University
Name
La Trobe University
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] 316266 0
None
Name [1] 316266 0
Address [1] 316266 0
Country [1] 316266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313423 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 313423 0
Ethics committee country [1] 313423 0
Australia
Date submitted for ethics approval [1] 313423 0
30/06/2016
Approval date [1] 313423 0
21/09/2016
Ethics approval number [1] 313423 0
16/24

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

Contacts
Principal investigator
Name 128110 0
Prof Della Forster
Address 128110 0
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country 128110 0
Australia
Phone 128110 0
+61 3 9479 8783
Fax 128110 0
Email 128110 0
D.Forster@latrobe.edu.au
Contact person for public queries
Name 128111 0
Robyn Matthews
Address 128111 0
The Royal Women’s Hospital
Locked Bag 300
Grattan St and Flemington Rd
Parkville VIC 3052
Country 128111 0
Australia
Phone 128111 0
+61 3 8345 2932
Fax 128111 0
Email 128111 0
R.Matthews@latrobe.edu.au
Contact person for scientific queries
Name 128112 0
Della Forster
Address 128112 0
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country 128112 0
Australia
Phone 128112 0
+61 3 9479 8783
Fax 128112 0
Email 128112 0
D.Forster@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, 30/2/2018, no end date.
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?

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.