Group Antenatal Care for Somali Born Women: a Feasibility Study Including Intervention Development and Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Women's overall rating of antenatal care
研究概览
简要总结
Somali-born women comprise one of the largest groups of immigrant women of childbearing age in Sweden, with increased risks for perinatal morbidity and mortality and poor experiences of care. Midwives in antenatal care have expressed a need for development of care tailored for this group of women.
The overall aim is to develop and test the acceptability and immediate impacts of group antenatal care for Somali women residing in Sweden, in an effort to improve their experiences of antenatal care, their knowledge about childbearing and the Swedish health care system, their emotional wellbeing and ultimately, their pregnancy outcomes.
The study includes four steps:
Step I is the preparation phase including needs assessment. Step II is the intervention development and evaluation tool development phase. Step III is the intervention phase, which includes the implementation and evaluation of the intervention using historical controls.
Step IV is the process evaluation and "lessons learned". Historical controls (n=80) have received standard individual care according to the national Swedish program for antenatal care, i.e. 8-9 appointments with a midwife during a normal pregnancy. Women in the intervention group (n=80) receive Group Antenatal Care provided in group sessions in a dialogue sensitive to language and cultural issues. The sessions are led by a midwife, assisted by a trained female Somali interpreter. 15 minutes for individual checkups in privacy are provided at end of the session.
Primary outcomes: Women's overall ratings of antenatal care and views about specific aspects of care are captured by core questions in the Migrant Friendly Maternity Care Questionnaire (MFMCQ); and emotional wellbeing by the Edinburgh Postnatal Depression Scale (EPDS).
Data are collected at recruitment, in gestational week 36 and at 2 months postpartum by means of face-to face interviews or interviews by telephone by a trained bilingual research assistant.
详细描述
Group antenatal care is developed in collaboration with Somali women, midwives and a reference group; to suit Somali born women's needs. The intervention is now evaluated for feasibility, acceptability and sustainability, by means of a historically controlled trial. The study is a non-randomized feasibility study in which the intervention and material has been developed parallel to the data collection for the control group; i.e. the historical controls receiving standard care.
Specific objectives for the study are;
- To establish with Somali-born women and antenatal caregivers the acceptability and feasibility of group antenatal care and to develop an appropriate model in order to improve outcomes for Somali-born women;
- To establish appropriate recruitment and data collection procedures and outcome measures in consultation with the Somali community and with care providers in order to evaluate the new model; and
- To implement and evaluate an agreed model of group antenatal care in partnership with the Somali community and antenatal caregivers.
Methods:
Step I was the preparation phase, including needs assessment, the development of contextual understanding and building a logic model for the project. A project steering group comprised of research team members, antenatal care midwives and representatives of the Somali community in Borlänge and North Stockholm was formed, to inform the intervention and the study. Somali born women in local community settings were encountered to develop a fuller understanding of issues and concerns about pregnancy and birth in a new country. The idea of group antenatal care was also discussed with women antenatal care midwives for its relevance, attractiveness and feasibility, and further how to best evaluate such a model. Focus group discussions were conducted with the following groups: 1) Somali born mothers 2) Somali born fathers; all with recent birth giving experience in Sweden, and 3) antenatal care midwives in multi-cultural settings in Sweden. The discussions were tape recorded and analysed by means of thematic analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Somali born women, both nulliparous and multiparous, <23 gestational weeks giving consent to access their patient record data
排除标准
- •Severe medical problem(s) requiring individual care only, as determined by the participating clinical practice
结局指标
主要结局
Women's overall rating of antenatal care
时间窗: 2 months postpartum
In general, were you happy with the healthcare you received? Always vs Often, Sometimes, Seldom, Never
Women's emotional wellbeing
时间窗: Late pregnancy and 2 months postpartum
Edinburgh Postnatal Depression Scale, mean values
次要结局
- Mode of birth(At birth)
- Epidural analgesia for labour pain(During active phase of labour)
- Number of visits(patient records. Just before the birth)
- Anemia during pregnancy(Gestational week 36)
- Induction of labour(Before active phase)
- Need for neonatal infant intensive care (NICU)(within 7 days from birth)
- Social support(Gestational week 36)
- Apgar score <7(At 5 minutes after the birth)
- Worries about the upcoming birth(Gestational week 36)
研究者
Erica Schytt
Associate professor
Karolinska Institutet