Deconstructing Maternal Burdens: doulas and the Community Unite for Health

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Women in the US have not reaped the benefits of the decline in worldwide maternalmortality (MM) rates (maternal deaths per 100,000 live births) as pregnancy‐relateddeaths (death of a woman while pregnant or within 1 year of the end of a pregnancy) haveincreased steadily for the past 3 decades. The incidence of perinatal depression andanxiety disorders is high in the US. An estimated 1 out of 7 to 10 pregnant women and 1out 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 emotionalsupport to patients and their support persons. The support doulas provide may beinstrumental in supporting maternal wellbeing and navigation of the healthcare system toobtain needed medical care. However, research on doulas have focused primarily onpregnancy and birth. Evidence as to the effectiveness of doula care in the postpartum isscant. This proposal will contribute to the sparse high‐level evidence to support the useand expansion of doula services to improve health for low‐income families.This is a pragmatic, two‐arm, Type 1 Effectiveness‐Implementation Hybrid randomizedcontrolled trial evaluating an enhanced doula support model, UNITE, against standardMedicaid covered doula care, in a socially high‐risk population. Pregnant individuals inthe study catchment area will be randomized to one of two groups: standard Medicaid doulacare, or UNITE doula care, which adds more visits starting earlier in pregnancy, morefrequent visits near the due date, several extended home visits in the first two monthspostpartum, and continued check‐ins through the first year after birth. UNITEparticipants will be engaged in clinic or home settings, in person and/or virtually, andwill 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 DoulaCollective, doulas are trained, supported to bill Medicaid, and mentored by anexperienced doula network.Participants in both arms will complete surveys at five time points from pregnancythrough one year postpartum to assess the intervention's effectiveness. The primaryoutcome is a composite measure of perinatal depressive and anxiety symptoms. Secondaryoutcomes include psychosocial measures, maternal morbidity and mortality, clinical andbirth outcomes, and knowledge of pregnancy warning signs. Implementation outcomes includereach, adoption, fidelity, and adaptation, will also be assessed.A nested qualitative component, including doula group debriefings and in‐depth interviewswith doula‐client dyads, will contextualize the RCT findings.The study is led by two Community Advisory Board (CAB), 1) Service Recipients ‐ Women ofchildbearing age, partners/ support persons, and 2) Service Providers ‐ doulas, medicalpersonnel (midwifery, obstetrics, primary care, mental health), communityrepresentatives, and policy makers. The CABs meet quarterly throughout the study.Findings are intended to inform a communication campaign and a state‐level policy onMedicaid reimbursement and the extension of doula services into the postpartum period.
Epistemonikos ID: c059e509f7379d7f74302130198f60b4ad524e29
First added on: Sep 03, 2026