Doula Support for Domestic Violence During Pregnancy

(Doula Thrive Trial)

Not yet recruiting at 2 trial locations

Overseen By Maya Ragavan

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Unable to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of doula support in reducing intimate partner violence (IPV) for pregnant individuals who have survived such violence. It compares two groups: one receiving regular check-ins from an IPV advocate and the other receiving comprehensive support from a doula (Doula Thrive). The doula group will receive assistance during pregnancy, birth, and postpartum, including clinic visits and other support. Individuals up to 22 weeks pregnant, who have experienced IPV, and live near Pittsburgh might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how doula support can improve outcomes for IPV survivors.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the doula intervention is safe for perinatal IPV survivors?

Research has shown that having a doula, like those in the Doula Thrive program, is generally safe and beneficial for pregnant women. Doulas are trained professionals who provide support during pregnancy and childbirth, offering emotional and practical assistance that can reduce stress and improve health outcomes.

In similar situations, having a doula has been linked to better birth experiences and reduced anxiety. Studies have not reported any major safety concerns with doula support. Instead, the focus remains on providing care and resources to assist women through this challenging time.

This trial does not involve testing a new drug or medical treatment, and the safety of having a doula is well-established. Doulas aim to ensure the well-being of both mother and baby without introducing any physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Doula Thrive intervention because it offers a unique approach to supporting pregnant individuals experiencing domestic violence. Unlike traditional treatments, which might primarily involve advocacy and helpline support, this intervention provides continuous, personalized care through a community-based doula. These doulas offer full-spectrum services, including attending clinic visits and the birth itself, as well as providing trauma-informed resources like a perinatal workbook. This comprehensive support system aims to empower participants and improve their overall well-being during a vulnerable time.

What evidence suggests that the Doula Thrive intervention is effective for reducing intimate partner violence during pregnancy?

Research has shown that having a doula can reduce stress and improve outcomes for pregnant women experiencing intimate partner violence (IPV). Doulas offer emotional and physical support during pregnancy and childbirth and help connect survivors to vital resources and a supportive community. Evidence suggests that this support can enhance mental health and provide a sense of safety for the mother. By offering care sensitive to past trauma, doulas can also lessen the impact of previous abuse around childbirth. In this trial, participants in the Doula group (intervention) will receive support from a community-based doula, potentially demonstrating the effectiveness of Doula Thrive in reducing IPV among women during this period. Meanwhile, the active control arm will include structured check-ins by a trained IPV advocate. ^{1 2 3 5 6}

Who Is on the Research Team?

Maya I Ragavan

Principal Investigator

University of Pittsburgh

Dara Mendez

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for perinatal individuals who have experienced intimate partner violence. Specific eligibility details are not provided, but typically participants would need to meet certain health and safety criteria relevant to the study's focus.

Inclusion Criteria

Perinatal IPV survivors are eligible if they are no more than 22 weeks gestation

Perinatal IPV survivors are eligible if they identify as an IPV survivor by answering affirmatively to a definition of experiencing IPV

Perinatal IPV survivors are eligible if they live within a 50 mile radius of Pittsburgh, Pennsylvania

Exclusion Criteria

Do not meet inclusion criteria

Cannot provide safe contact information

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Doula Intervention

Participants receive full-spectrum doula services from 22 weeks gestation through the birthing period

6 months

4 structured visits, additional unstructured support

Postpartum Doula Support

Continued doula support and connection to resources during early postpartum period

6 months

Follow-up

Participants are monitored for changes in IPV and other secondary outcomes

12 months

Assessments at 3, 6, and 12 months post-enrollment

What Are the Treatments Tested in This Trial?

Interventions

• Doula Thrive

Trial Overview The Doula Thrive Clinical Trial compares a doula intervention called 'Doula Thrive' with an active control named 'Thrive' to see which is more effective at reducing intimate partner violence among survivors during the perinatal period.

How Is the Trial Designed?

Group I: Doula group (intervention) Experimental Treatment 1 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.

Group II: Active control arm Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07165860

Clinical Trial to Reduce Perinatal Intimate Partner Violence Novel Doula Intervention to Leverage Clinic-community Connections to Support Perinatal Intimate Partner Violence Survivors. Conditions. Domestic Violence ...

2. withpower.com withpower.com/trial/phase-perinatal-problems-8-2025-04a4e

Doula Support for Domestic Violence During Pregnancy ... ... with an active control named 'Thrive' to see which is more effective at reducing intimate partner violence among survivors during the perinatal period. How ...

3. htsyndication.com htsyndication.com/health-daily-digest/article/clinical-trial%3A-doula-thrive-clinical-trial-to-reduce-perinatal-intimate-partner-violence/93155616

Doula Thrive Clinical Trial to Reduce Perinatal Intimate ... Clinical Trial: Doula Thrive Clinical Trial to Reduce Perinatal Intimate Partner Violence. Posted On: 2025-09-11. Health & Lifestyle Health ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0266613820300176

Evidence and guidelines for trauma-informed doula care Domestic/intimate partner violence, sexual violence, and childhood maltreatment along with subsequent perinatal PTSD can also increase the risk of ...

5. pretermbirthca.ucsf.edu pretermbirthca.ucsf.edu/sites/g/files/tkssra15601/files/wysiwyg/social%20determinants%20and%20health%20doula%20support.pdf

Doula Support during Pregnancy and Childbirth Conclusions: Access to doula services for pregnant women who are at risk of poor birth outcomes ... ner violence and exposure to abuse are more likely to have ...

6. researchonline.stthomas.edu researchonline.stthomas.edu/view/pdfCoverPage?instCode=01CLIC_STTHOMAS&filePid=13439847800003691&download=true

Partnership with Doulas & Domestic Violence Services by When this is combined with the. Page 10. PREGNANCY AND DOMESTIC VIOLENCE. 5 understanding of how abuse may impact the mother and infants' ability to thrive, it ...