Description

Women in the US have not reaped the benefits of the decline in worldwide maternal mortality (MM) rates (maternal deaths per 100,000 live births) as pregnancy-related deaths (death of a woman while pregnant or within 1 year of the end of a pregnancy) have increased steadily for the past 3 decades. The incidence of perinatal depression and anxiety disorders is high in the US. An estimated 1 out of 7 to 10 pregnant women and 1 out of 5 to 8 postpartum women will develop depressive and/or anxiety disorder.

A doula is a non-medical person who provides informational, physical and emotional support to patients and their support persons. The support doulas provide may be instrumental in supporting maternal wellbeing and navigation of the healthcare system to obtain needed medical care. However, research on doulas have focused primarily on pregnancy and birth. Evidence as to the effectiveness of doula care in the postpartum is scant. This proposal will contribute to the sparse high-level evidence to support the use and expansion of doula services to improve health for low-income families.

This is a pragmatic, two-arm, Type 1 Effectiveness-Implementation Hybrid randomized controlled trial evaluating an enhanced doula support model, UNITE, against standard Medicaid covered doula care, in a socially high-risk population. Pregnant individuals in the study catchment area will be randomized to one of two groups: standard Medicaid doula care, or UNITE doula care, which adds more visits starting earlier in pregnancy, more frequent visits near the due date, several extended home visits in the first two months postpartum, and continued check-ins through the first year after birth. UNITE participants will be engaged in clinic or home settings, in person and/or virtually, and will receive emotional and physical support, education, referrals to community resources, and screening for risk factors for adverse outcomes.

The study also builds the doula workforce it depends on. Through the UNITE Doula Collective, doulas are trained, supported to bill Medicaid, and mentored by an experienced doula network.

Participants in both arms will complete surveys at five time points from pregnancy through one year postpartum to assess the intervention's effectiveness. The primary outcome is a composite measure of perinatal depressive and anxiety symptoms. Secondary outcomes include psychosocial measures, maternal morbidity and mortality, clinical and birth outcomes, and knowledge of pregnancy warning signs. Implementation outcomes include reach, adoption, fidelity, and adaptation, will also be assessed.

A nested qualitative component, including doula group debriefings and in-depth interviews with doula-client dyads, will contextualize the RCT findings.

The study is led by two Community Advisory Board (CAB), 1) Service Recipients - Women of childbearing age, partners/ support persons, and 2) Service Providers - doulas, medical personnel (midwifery, obstetrics, primary care, mental health), community representatives, and policy makers. The CABs meet quarterly throughout the study.

Findings are intended to inform a communication campaign and a state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.