Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,125
- 试验地点
- 16
- 主要终点
- Infant immunization completion rate per national immunization schedule
研究概览
简要总结
The proposed study will evaluate the effectiveness of an integrated group postpartum and well-child care model, compared to individual (usual) postnatal and well-child care, on maternal and child health outcomes. Results will provide clinical evidence for improved maternal and infant health care in the first year postpartum. The study will inform and provide lessons learned to advance maternal and infant health service delivery models in low resource settings.
详细描述
A cluster randomized controlled trial design with mixed methods will be used to determine the impact and comparative effectiveness of group versus usual individual care with postpartum women and the women's infants in 16 clinics across Zomba District, Malawi. Data is collected at baseline, 6- and 12-months. Women are nested within the postpartum/well-child care group for the intervention. In the control arm, dyads will be grouped based on order of entry within each site. The first 10 dyads will form "group" 1, the second 10 dyads "group" 2, etc. The investigators will also explore the health and health-related social needs that arise in the 12 months after birth for both women and the women's infants through in-depth interviews as well as implementation barriers and facilitators for group postpartum and well-child care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Week 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women presenting for their 1-week postnatal care visit with their infant at a study site clinic.
- •One infant is less than 4 weeks old.
- •Able to speak and understand Chichewa.
- •Adolescents 15-17 must bring parent/guardian for consent/assent. Infants included as part of mother-infant dyad.
- •Midwife or HSA serving as group care co-facilitator or key stakeholders in MoH/Zomba District/clinical administration
- •Able to speak Chichewa and/or English.
排除标准
- •Under age
- •Serious physical or mental illness or marked cognitive impairment preventing informed consent.
- •Inability to participate in full intervention
- •Multiple infants (e.g. twins, triplets)
- •Serious physical or mental illness or marked cognitive impairment preventing informed consent.
研究组 & 干预措施
Group Care
干预措施: Group Care (Behavioral)
Usual care
结局指标
主要结局
Infant immunization completion rate per national immunization schedule
时间窗: 6 months, and 12 months after birth
Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: baseline, 6 months, and 12 months postpartum
The EPDS is a 10-item self-report scale with scores ranging from 0-30; higher scores indicate more depressive symptoms.
Infant immunization completion rate per national immunization schedule
时间窗: baseline, 6 months, and 12 months after birth
次要结局
- Partner communication as measured by relationship quality survey(baseline, 6 months, and 12 months postpartum)
- Maternal anemia - hemoglobin level measured by point-of-care bloodspot test(baseline and 12 months postpartum)
- Infant mortality as measured by clinic reporting and parent's self-report(6 months and 12 months after birth)
- Number of Participants Exclusively breastfeeding at 6 months after birth(6 months postpartum)
- Infant growth as measured by weight-for-age per growth standards(baseline, 6 months, and 12 months after birth)
- Infant growth as measured by length-for-age per growth standards(baseline, 6 months, 12 months after birth)
- Infant nutritional status as measured by mid-upper arm circumference (MUAC)(6 months and 12 months after birth)
- Infant anemia as measured by point-of-care hemoglobin bloodspot test(12 months after birth)
- Number of participants using a family planning method(baseline, 6 months and 12 months postpartum)
- Number of Participants who recall postnatal care content as measured by structured survey(6 and 12 months postpartum)
- Self-reported peer connectedness as measured by study survey(6 and 12 months postpartum)
- Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)(baseline, 6 months and 12 months postpartum)
- Maternal nutrition as measured by dietary diversity survey(baseline, 6 months, and 12 months postpartum)
- Maternal anemia - hemoglobin level measured by point-of-care bloodspot test(baseline, 6 months, and 12 months postpartum)
- Hypertension as measured by blood pressure assessment(baseline, 6 months, and 12 months postpartum)
- Postpartum anxiety as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7)(baseline, 6 months, and 12 months postpartum)
- Maternal mortality as measured by clinic reporting(6 months and 12 months postpartum)
- Child development as measured by the Malawi Developmental Assessment Tool (MDAT)(6 months and 12 months after birth)
- Infant mortality as measured by clinic reporting(6 months and 12 months after birth)