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1.
Pilot Feasibility Stud ; 10(1): 81, 2024 May 20.
Article in English | MEDLINE | ID: mdl-38769553

ABSTRACT

BACKGROUND: In group-based pregnancy models, antenatal care and childbirth/parenting education are provided in groups of eight to 10 women, usually with two midwives, and six to eight sessions. Current evidence is inconclusive regarding potential benefit or harm. We aimed to explore the feasibility of implementing an adequately powered randomised controlled trial (RCT). METHODS: A two-arm pilot RCT was conducted in a tertiary maternity hospital in Melbourne, Australia. Women were randomly allocated to either the intervention to receive group-based antenatal care and education (group care) or to usual care, which included hospital-based midwife, caseload midwifery, team midwifery, or GP shared care. Participants were English-speaking, primiparous, low risk, and < 24 weeks gestation at booking. DATA COLLECTION: feasibility measures throughout pilot, baseline questionnaire at recruitment, clinical outcome data from the medical record, and a telephone-administered questionnaire 6 weeks postpartum. A focus group explored midwives' views. RESULTS: Seventy-four women were recruited from May to June 2017 (group care = 40, usual care = 34). Study uptake was 35%. Women allocated to group care rated their overall pregnancy care more highly (88% good/very good vs 77% in usual care). There was no evidence of harm related to group care. Overarching themes from the midwives were that group care helped 'build connections' and 'empower women'. All midwives would work in the model again and believed it should be expanded. CONCLUSION: Group care was acceptable to both women and midwives with no evidence of harm. The pilot demonstrated the feasibility of undertaking a large adequately powered RCT, important given the inconclusive evidence on clinical outcomes regarding the model, and its current relatively widespread implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000858695.

3.
BMC Pregnancy Childbirth ; 3(1): 5, 2003 Aug 29.
Article in English | MEDLINE | ID: mdl-12946279

ABSTRACT

BACKGROUND: It has proven difficult to reach World Health Organization (WHO) recommendations that infants be exclusively breastfed from birth to six months of age 12, yet there is limited knowledge about interventions that are effective in increasing breastfeeding initiation and duration. Particularly lacking is evidence about how to maintain breastfeeding rates in countries which already have a high initiation of breastfeeding. This study aims to determine whether mid-pregnancy breastfeeding education, with a focus on either attitudes to breastfeeding or on technical aspects of breastfeeding, has an effect on rates of breastfeeding initiation and duration. Secondary aims of the study are to: explore what factors might affect the duration of breastfeeding and evaluate the interventions from the participant and childbirth facilitator perspectives. METHODS/DESIGN: A randomised controlled trial (RCT) design will be used. Women having their first baby, and planning to give birth as public patients at the Royal Women's Hospital (RWH), Melbourne, will be approached at 18-20 weeks of pregnancy and invited to participate in the study. Participants will be randomly allocated to a control group or one of two group interventions: a previously designed and trialled tool to teach practical aspects of breastfeeding or an exploration of family attitudes to breastfeeding. The latter was developed and piloted by the investigators in conjunction with the group facilitators, prior to trial commencement. The interventions are planned to take place at 20-25 weeks. Data will be collected by questionnaire at recruitment, at interview in hospital after the birth and by telephone interview six months later. Medical/obstetric outcomes will be obtained from the medical record. The sample size (972) was calculated to identify an increase in breastfeeding initiation from 75 to 85% and an increase from 40 to 50% in breastfeeding at six months.

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