RecruitingACTRN12622000607774

Exploring the impact of midwife-led group antenatal care on caesarean section rates and infant health: a multi-site randomised controlled trial

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


Sponsor

Della Forster

Enrollment

3,061 participants

Start Date

Jan 2, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Most pregnancies in Australia are managed through standard individual antenatal appointments with a midwife or doctor. This study tests a different model: midwife-led group antenatal care, where small groups of pregnant women with similar due dates meet together regularly with the same midwife throughout pregnancy. This model combines clinical care with peer support and education in a single visit. The trial is being run at two sites in Victoria and compares outcomes between women who receive group care and those who receive standard individual care. The main outcomes include rates of caesarean section and rates of premature or low-birthweight birth. Women who give birth in a group care programme also tend to report higher satisfaction with their pregnancy experience. You may be eligible if you are expecting your first baby, carrying a single pregnancy, are less than 22 weeks pregnant, attending a public hospital at one of the study sites, are assessed as low to moderate obstetric risk, and can speak and understand English. Women with high-risk pregnancies, drug or alcohol issues needing specialist care, or known major fetal problems are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 s

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.


Locations(4)

The Royal Women's Hospital - Parkville

VIC, Australia

Mercy Hospital for Women - Heidelberg

VIC, Australia

Frankston Hospital - Frankston

VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

VIC, Australia

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ACTRN12622000607774


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