Recruiting

Doula Intervention

Sponsor:

University of Pittsburgh

Code:

NCT07165860

Conditions

Domestic Violence

Perinatal Problems

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Doulas

Thrive

Study Details

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

Study ID

NCT07165860

Start date

Nov 1, 2025

Status verified date

Apr, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Active control arm

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.

experimental: Doula group (intervention)

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.

Interventions

Doulas

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

Thrive

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

Primary outcome measure

  • Perinatal physical, sexual, or emotional abuse (past 3 months) [ Time Frame: baseline, 3 months, 6 months, 12 months ]
  • Substance use coercion (past 3 month) [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
  • Mental health coercion (past 3 month) [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
  • Economic Abuse (past 3 month) [ Time Frame: baseline, 3 month, 6 months, and 12 months ]
  • Reproductive Coercion (past 3 months) [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
  • Sleep coercion (past 3 months) [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
  • Past 3-month Digital coercion [ Time Frame: baseline, 3, 6, and 12 months ]
  • Past 3 month Health-related coercion [ Time Frame: baseline, 3, 6, and 12 months ]

Central Contacts and Locations

Central contacts

Maya Ragavan

4126926545ragavanm@chp.edu

Maya Ragavan

16506449954ragavanm@chp.edu

Locations

The Midwife Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15222

Contacts

Emily McGahey

(412) 321-6880e.mcgahey@midwifecenter.org

Family Medicine Department

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Stacy Bartlett

412-383-2377bartlettsj2@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • intimate partner violence
  • perinatal health
  • doula

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-16.