Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 576
- 试验地点
- 4
- 主要终点
- Number of Recommended Perinatal Care Components Received
研究概览
简要总结
This study will develop and test an intervention, called the Well-Mama intervention, which includes the use of a checklist by Community Doula Navigators to support pregnant women. Participants will be randomized to either receive standard perinatal care or standard perinatal care plus the Well-Mama intervention.
详细描述
Black, Indigenous, and People of Color (BIPOC) women experience profound maternal health disparities in the US, including rising rates of maternal mortality and severe maternal morbidity. This study will develop a Well-Mama intervention for pregnant and postpartum BIPOC women, centered around Community Doula Navigators conducting in-person and telehealth check-ins on 5 priority areas (mental health, cardiovascular symptoms, safety, opioid/substance abuse, and social support), supplemented with virtual support groups and labor support. The investigators will conduct a randomized trial to test whether the Well-Mama intervention increases BIPOC women's receipt of prenatal and postpartum care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1) Pregnant individuals that are age 15-49 years; (2) uninsured or have public insurance (i.e., Medicaid); (3) singleton pregnancy <32 weeks gestation; and (4) not cognitively impaired
排除标准
- •Already receiving/enrolled in another perinatal care program beyond standard care, such as group prenatal care, maternity home, or employing their own doula
研究组 & 干预措施
Standard Care
Participants randomized to standard care will be offered prenatal and postpartum care in accordance with site-specific procedures based on AAP and ACOG Guidelines for Perinatal Care. The initial intake appointment, involving a comprehensive visit with physical exam, medical and psychosocial history, laboratory testing, and education would optimally occur in the 1st trimester. Subsequent prenatal visits, per ACOG, is monthly for the first 28 weeks, biweekly for weeks 28-36, and weekly after 36 weeks. More frequent visits may be offered to women at high risk. In addition, some sites may offer supports such as nutritional counseling, childbirth education, and case management. A comprehensive postpartum care visit would typically occur within the first 6 weeks of birth, involving a physical examination, lab tests, and immunizations.
Standard Care with Well-Mama Intervention
Participants will receive standard perinatal care plus the Well Mama intervention, including the Well Mama Checklist, assistance from a Community Doula Navigator, and virtual support groups.
干预措施: Standard Care with Well-Mama Intervention (Behavioral)
结局指标
主要结局
Number of Recommended Perinatal Care Components Received
时间窗: Baseline through 1 year postpartum
The primary outcome will be a composite proportion of perinatal care components across three domains, including prenatal care, postpartum care, and social determinants of health content compared between participants in the intervention and control arms.
次要结局
- Rate of experiences of racism and discrimination(Baseline through 1 year postpartum)
- Number of participants with low birth weight newborns(Baseline through 1 year postpartum)
- Level of self-efficacy for dealing with stressful situations(Baseline through 1 year postpartum)
- Level of patient engagement in healthcare management(Baseline through 1 year postpartum)
- Level of trust in health care system(Baseline through 1 year postpartum)
- Number of participants with NICU admissions(Baseline through 1 year postpartum)
研究者
Melissa Simon
Vice Chair of Research, Professor of Obstetrics and Gynecology
Northwestern University