Doula Model of Care for Perinatal Support

Overseen By Elizabeth Norton, MPH

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Unable to consent, PI discretion

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

Compensation: Varies

Number of Visits: 4

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether having a doula (a trained birth companion) can improve the birthing experience and outcomes for Black individuals giving birth at the Hospital of the University of Pennsylvania. Participants will receive either standard prenatal and postpartum care or additional support from a doula, which includes prenatal visits, support during labor, and postpartum visits. The study aims to determine if this extra support can reduce stress and improve well-being, particularly by examining changes in depression levels. Those who are currently pregnant, identify as Black, plan to deliver at the hospital, and are in the second trimester might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance birthing experiences for Black individuals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Doula Model of Care is safe for perinatal support?

Research has shown that having a doula during pregnancy and birth is generally safe and well-received. Studies indicate that doula support can lead to positive outcomes. For instance, one study found that women with a doula were 52.9% less likely to need a cesarean delivery. They also had a 57.5% lower chance of experiencing postpartum depression, a type of depression some women face after giving birth.

Overall, these findings suggest that having a doula can improve the birth experience without major safety concerns. While more research could help clarify all the benefits, current evidence supports the safety of using doulas during childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Doula Model of Care for perinatal support because it offers a more personalized and holistic approach compared to the usual medical care. Unlike standard care, which primarily focuses on the medical aspects of childbirth, this model emphasizes emotional support and personalized guidance throughout the prenatal, labor, and postpartum stages. Certified doulas are there to provide continuous care, which can help reduce stress and improve overall childbirth experiences. This approach could lead to better maternal and infant health outcomes, making it a promising complement to existing prenatal and postpartum services.

What evidence suggests that the Doula Model of Care is effective for improving outcomes for Black birthing people?

Research has shown that having a doula—a trained support person—during pregnancy and childbirth can lead to better health outcomes. In this trial, participants in the Doula Model of Care arm will receive services from a certified doula, who will provide emotional and practical support. Studies have found that having a doula is linked to fewer C-sections and early births. Some evidence suggests that doulas can lower the risk of mood and anxiety issues after birth, especially in communities with limited healthcare access. Overall, having a doula can greatly benefit the health and well-being of both parents and babies. ^{1 4 6 7 8}

Who Is on the Research Team?

Sindhu K Srinivas, MD, MSCE

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for Black birthing individuals who are patients at the Hospital of the University of Pennsylvania. It's designed to see if having a doula—a trained professional providing continuous support during pregnancy, birth, and postpartum—can improve their mental health outcomes.

Inclusion Criteria

Pregnant patients who self-identify as Black

Plan to deliver at HUP

Patients must be able to read and understand English

Exclusion Criteria

Unable to provide written consent by being unable to read or sign informed consent

PI Discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Care

Participants receive 2 prenatal visits with a certified doula or standard prenatal care

Varies

2 visits (in-person)

Intrapartum Support

Continuous support during labor and delivery provided by a certified doula

At delivery

Postpartum Care

Participants receive 2 postpartum visits with a certified doula or standard postpartum care

6 weeks postpartum

2 visits (in-person)

Follow-up

Participants are monitored for depression, self-efficacy, and birth satisfaction up to 6 weeks postpartum

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Doula Model of Care

Trial Overview

The study compares two types of care: one group receives standard prenatal, labor, delivery, and postpartum care; the other gets additional support from a certified doula with visits before and after birth. The focus is on reducing bias and mistrust to better experience and outcomes.

How Is the Trial Designed?

Group I: Doula Model of Care Experimental Treatment 1 Intervention

Participants will be offered to receive services by the certified doula. The doula will provide emotional support, prenatal support, intrapartum support and will facilitate the receipt of postpartum health care for the patient.

Group II: Usual Care Active Control 1 Intervention

Participants will continue to receive prenatal, labor and delivery, and postpartum care as they normally would if not in the study. Patients who seek doula services on their own will be allowed to do so

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

March of Dimes

Collaborator

Trials

24

Recruited

30,500+

Published Research Related to This Trial

Doulas provide essential support during the perinatal period, leading to improved outcomes such as decreased preterm births and increased rates of breastfeeding initiation, based on a review of 34 articles.

Doula support is particularly beneficial for Black patients, showing promise in reducing racial disparities in maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doula Care: A Review of Outcomes and Impact on Birth Experience. Ramey-Collier, K., Jackson, M., Malloy, A., et al.[2023]

A study involving 47 maternity care practitioners revealed that while many support the role of doulas in providing emotional and physical support during childbirth, there are mixed feelings about their integration into hospital teams, often due to cultural differences between traditional medical practices and natural birth philosophies.

To improve collaboration between doulas and hospital staff, it is essential to provide training on the doula model of care, clearly define roles, and foster mutual respect, which can enhance maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-based maternity care practitioners' perceptions of doulas. Neel, K., Goldman, R., Marte, D., et al.[2020]

A new NICU-focused trigger tool was developed and tested, revealing a high incidence of adverse events in hospitalized children, with 554 unique adverse events identified across 749 charts, averaging 0.74 events per patient.

The study found that 56% of these adverse events were preventable, highlighting the need for improved safety measures, as only 8% were reported through traditional hospital reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Sharek, PJ., Horbar, JD., Mason, W., et al.[2021]

The Safety Program for Perinatal Care (SPPC) was implemented in 43 labor and delivery units, covering 97,740 deliveries, and led to improvements in teamwork, communication, and overall safety culture among staff.

While the program resulted in a slight decrease in the Modified Adverse Outcome Index (MAOI) from 5.03% to 4.65%, the impact on specific maternal and neonatal adverse events was mixed, with some indicators showing improvement and others, like neonatal birth trauma, showing an increase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Agency for Healthcare Research and Quality's Safety Program for Perinatal Care. Kahwati, LC., Sorensen, AV., Teixeira-Poit, S., et al.[2020]

In a pilot study involving 12 women who received doula support during hospital births, participants reported that doulas provided significant emotional and practical support, enhancing their overall birthing experience.

Key themes from the interviews included the doulas' ability to offer reassurance, encouragement, and tailored support, which fulfilled the women's desire for guidance from an experienced individual, indicating the positive impact of doula support in the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's Perceptions of Their Doula Support. Koumouitzes-Douvia, J., Carr, CA.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10292163/

The Effect of Doulas on Maternal and Birth Outcomes

Doula care in perinatal care was significantly correlated with positive delivery outcomes including reduced cesarean and premature deliveries.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949856225000297

A qualitative study of doulas providing emotional support ...

Research on doulas is growing and suggests that doula support is associated with improved perinatal health experiences and outcomes, including reductions in ...

3.

aspe.hhs.gov

aspe.hhs.gov/sites/default/files/documents/dfcd768f1caf6fabf3d281f762e8d068/ASPE-Doula-Issue-Brief-12-13-22.pdf

Doula Care and Maternal Health: An Evidence Review

Doula support during pregnancy, birth, and during the postpartum period has been shown to be an effective best practice that can enhance the ...

4.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1272513/full

The role of doulas in supporting perinatal mental health

Results: Doulas and clients reported positive relationships, supported by congruence in culture, language, and lived experiences. Doulas varied ...

5.

bmcpregnancychildbirth.biomedcentral.com

bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07855-y

Community-based doulas and medicaid expansion: a ...

Doula care across the perinatal period may significantly reduce the odds of perinatal mood and anxiety disorders particularly in communities ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1049386724000215

United States Doula Programs and Their Outcomes

Some studies have found associations between doula care and improved clinical outcomes for birthing people and infants, the evidence is limited.

7.

nyc.gov

nyc.gov/assets/doh/downloads/pdf/csi/doula-report-2025.pdf

The State of Doula Care in NYC, 2025

The NYC Health Department has released the third full year of provisional data on doula support during pregnancy and during childbirth, as collected on the NYC ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9257331/

Doula care across the maternity care continuum and impact ...

Women who received doula care had 52.9% lower odds of cesarean delivery (OR: 0.471 95% CI: 0.29–0.79) and 57.5% lower odds of postpartum depression/postpartum ...