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Exploring the feasibility and acceptability of group antenatal care and education: a pilot randomised controlled trial

Exploring the feasibility and acceptability of group antenatal care and education for primigravid women: a pilot randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000858695
Acronym
GEM Care - pilot
Enrollment
75
Registered
2023-08-09
Start date
2017-05-29
Completion date
2017-06-22
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. Group pregnancy care (where women have care and education in a group of 8-10 women) is very popular among women and midwives but needs further testing for safety. This small pilot study will explore whether we can successfully do a larger study in Victoria, Australia that will provide evidence for the safety of this pregnancy model of care.

Interventions

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.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 7, 2026