RecruitingNot Applicable

Clinical Trial to Reduce Perinatal Intimate Partner Violence

United States250 participantsStarted 2025-11-01

Plain-language summary

This is a two-armed, fully powered hybrid type 1 trial to test the effectiveness of a doula intervention compared with an active control in reducing intimate partner violence (IPV) among perinatal IPV survivors

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perinatal physical, sexual, or emotional abuse (past 3 months)

Timeframe: baseline, 3 months, 6 months, 12 months

Substance use coercion (past 3 month)

Timeframe: baseline, 3 months, 6 months, and 12 months

Mental health coercion (past 3 month)

Timeframe: baseline, 3 months, 6 months, and 12 months

Economic Abuse (past 3 month)

Timeframe: baseline, 3 month, 6 months, and 12 months

Reproductive Coercion (past 3 months)

Timeframe: baseline, 3 months, 6 months, and 12 months

Sleep coercion (past 3 months)

Timeframe: baseline, 3 months, 6 months, and 12 months

Past 3-month Digital coercion

Timeframe: baseline, 3, 6, and 12 months

Trial details

NCT IDNCT07165860

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11-01

Contact for this trial

Maya Ragavan

4126926545 ragavanm@chp.edu

View on ClinicalTrials.gov More Domestic Violence trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Perinatal physical, sexual, or emotional abuse (past 3 months)

Timeframe: baseline, 3 months, 6 months, 12 months

Substance use coercion (past 3 month)

Timeframe: baseline, 3 months, 6 months, and 12 months

Mental health coercion (past 3 month)

Timeframe: baseline, 3 months, 6 months, and 12 months

Economic Abuse (past 3 month)

Timeframe: baseline, 3 month, 6 months, and 12 months

Reproductive Coercion (past 3 months)

Timeframe: baseline, 3 months, 6 months, and 12 months

Sleep coercion (past 3 months)

Timeframe: baseline, 3 months, 6 months, and 12 months

Past 3-month Digital coercion

Timeframe: baseline, 3, 6, and 12 months