Doula support to reduce partner violence during pregnancy and early postpartum

Novel Doula Intervention to Leverage Clinic-community Connections to Support Perinatal Intimate Partner Violence Survivors

This project will test whether pairing pregnant people who have experienced intimate partner violence with IPV-trained doulas during pregnancy, birth, and the first months after delivery reduces partner violence and improves related health outcomes compared with an active control.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Pittsburgh (other)
• Locations: 3 sites (Pittsburgh, Pennsylvania and 2 other locations)
• Trial ID: NCT07165860 on ClinicalTrials.gov

What this trial studies

This is a two-arm randomized trial enrolling 250 perinatal people who identify as intimate partner violence (IPV) survivors at three Pittsburgh sites. Participants are randomized to receive full-spectrum support from an IPV-trained community doula from ~22 weeks gestation through six months postpartum, or to an active control of two structured intakes from a victim services agency. The primary outcome is change in IPV coercive behaviors from baseline to 12 months; secondary outcomes include cannabis and tobacco use, depressive and anxiety symptoms, and unmet basic needs, with assessments at enrollment, 3, 6, and 12 months. The study also examines mediators and moderators of effect and collects implementation outcomes to inform real-world delivery.

Who should consider this trial

Good fit: Ideal candidates are people aged 18 or older, up to 24 weeks 6 days gestation (baseline around 22 weeks), who identify as IPV survivors, speak English or Spanish, live within 50 miles of Pittsburgh, and can provide safe contact information or accept a study cell phone.

Not a fit: People who are incarcerated, unable to consent, cannot provide safe contact information or a study phone, are beyond the gestational eligibility window, or do not identify as IPV survivors are unlikely to benefit from enrolling in this trial.

Why it matters

Potential benefit: If successful, the intervention could reduce intimate partner violence among perinatal survivors and improve mental health, substance use, and basic needs during pregnancy and the first year postpartum.

How similar studies have performed: While doulas have demonstrated benefits for birth outcomes and patient experience, using IPV-trained doulas specifically to reduce partner violence is a relatively novel approach with limited prior randomized trial evidence.

Eligibility criteria

Inclusion Criteria: Perinatal IPV survivors are eligible if they:

* 1\) feel comfortable completing the study in Spanish or English
* 2\) are age 18 or older
* 3\) are no more than 24 weeks 6 days gestation (note: participants enrolled earliest at 18 weeks, baseline at 22 weeks with a 3 week window)
* 4\) identify as an IPV survivor by answering affirmatively to a definition of experiencing IPV
* 5\) live within a 50 mile radius of Pittsburgh, Pennsylvania
* 6\) able to provide safe and complete contact information or take a study cell phone

Exclusion Criteria:

* Unable to consent
* Do not meet inclusion criteria
* Cannot provide safe contact information or take a study cell phone
* Incarcerated

Where this trial is running

Pittsburgh, Pennsylvania and 2 other locations

• Magee Women's Hospital — Pittsburgh, Pennsylvania, United States (NOT_YET_RECRUITING)
• The Midwife Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
• Family Medicine Department — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Maya I Ragavan — University of Pittsburgh
• Study coordinator: Maya Ragavan

Conditions: Domestic Violence, Perinatal Problems, intimate partner violence, perinatal health, doula