Clinical Trial to Reduce Perinatal Intimate Partner Violence

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07165860
Status
Recruiting
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Conditions

  • Domestic Violence
  • Perinatal Problems

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Doulas — BEHAVIORAL
    The intervention will be pairing intimate partner violence survivors with a trained doula
  • Thrive — BEHAVIORAL
    The active control arm will include pairing intimate partner violence survivors with IPV advocates

Study Details

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

Key Dates

Start date
Nov 1, 2025
Status verified
Apr 2026
Primary completion
Nov 1, 2028
Completion
May 1, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Perinatal physical, sexual, or emotional abuse (past 3 months) [ Time Frame: baseline, 3 months, 6 months, 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Family Medicine DepartmentPittsburghPennsylvania15260
Stacy Bartlett
[email protected]
412-383-2377
Magee Women's HospitalPittsburghPennsylvania15213
The Midwife CenterPittsburghPennsylvania15222
Emily McGahey
[email protected]
(412) 321-6880

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