Clinical Trial to Reduce Perinatal Intimate Partner Violence

NCT07165860 | Recruiting DMC

• 2 other identifiers: STUDY24080042R01NR021484
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Domestic Violence; Perinatal Problems

Keywords

intimate partner violence; perinatal health; doula

Outcome Measures

Primary Outcomes (8)

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

  15 item Composite Abuse Scale Short form, scale is 0 to 5 and 15 items are added for a summary score, higher number means more IPV

  baseline, 3 months, 6 months, 12 months

• Substance use coercion (past 3 month)

  5 item measure answer choices and yes/no

  baseline, 3 months, 6 months, and 12 months

• Mental health coercion (past 3 month)

  5 item mental health coercion survey with yes and no answer choices

  baseline, 3 months, 6 months, and 12 months

• Economic Abuse (past 3 month)

  12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse

  baseline, 3 month, 6 months, and 12 months

• Reproductive Coercion (past 3 months)

  9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion

  baseline, 3 months, 6 months, and 12 months

• Sleep coercion (past 3 months)

  1 item sleep coercion measure (investigator developed, yes/no)

  baseline, 3 months, 6 months, and 12 months

• Past 3-month Digital coercion

  4 item measure on digital coercion, scored yes or no

  baseline, 3, 6, and 12 months

• Past 3 month Health-related coercion

  3 item measure focused on coercion experienced related to healthcare, health, or medical choices, score yes/no

  baseline, 3, 6, and 12 months

Secondary Outcomes (6)

• Substance use

  baseline

• Tobacco use

  baseline, 3 months, 6 months, 12 months

• Depressive symptoms

  baseline, 3 months, 6 months, 12 months

• Anxiety

  baseline, 3 months, 6 months, and 12 months

• Unmet basic needs (financial, food, and housing insecurity)

  Baseline, 12 months

Other Outcomes (14)

• Resource utilization

  baseline, 3 months, 6 months, 12 months

• Safety related empowerment

  baseline, 3 months, 6 months, 12 months

• Trust of healthcare, doula and IPV advocate

  baseline, 3 months, 6 months, 12 months

Study Arms (2)

Active control arm

ACTIVE COMPARATOR

The active control arm will include two structured check-ins by a trained intimate partner violence advocate from a local victim services agency. The IPV advocate will check in twice: once prenatally (after randomization) and the next postpartum. All participants in the active control arm will have access to the 24/7 helpline.

Behavioral: Thrive

Doula group (intervention)

EXPERIMENTAL

The intervention arm will include support rom a community-based doula connected with an IPV survivor during the second trimester and followed for 6 months. The doulas will provide full-spectrum services, which include attending clinic visits, support during the delivery, telephone and virtual check-ins, and connection to resources. Doulas have 4 structured visits (4 hours) and the rest of the time will be unstructured. Doulas will also attend the participant's birth. Doulas will provide a trauma-informed perinatal workbook to the participants that our team developed.

Behavioral: Doulas

Interventions

Thrive BEHAVIORAL

The active control arm will include pairing intimate partner violence survivors with IPV advocates

Active control arm

Doulas BEHAVIORAL

The intervention will be pairing intimate partner violence survivors with a trained doula

Doula group (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) feel comfortable completing the study in Spanish or English
• \) are age 18 or older
• \) 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)
• \) identify as an IPV survivor by answering affirmatively to a definition of experiencing IPV
• \) live within a 50 mile radius of Pittsburgh, Pennsylvania
• \) able to provide safe and complete contact information or take a study cell phone

You may not qualify if:

• Unable to consent
• Cannot provide safe contact information or take a study cell phone
• Incarcerated

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

The Midwife Center

Pittsburgh, Pennsylvania, 15222, United States

RECRUITING

Family Medicine Department

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MeSH Terms

Interventions

Doulas; Nicotine

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Maya I Ragavan

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Dara Mendez

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Ragavan

CONTACT

4126926545; ragavanm@chp.edu

Maya Ragavan

CONTACT

16506449954; ragavanm@chp.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The trial will be blinded to the investigators and participants will be unblinded if a participant is experiencing distress or needs support from the primary investigator
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)