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

Trial Summary

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 data supports the effectiveness of the Doula Model of Care treatment?

Research shows that having a doula (a trained support person) during pregnancy and childbirth can lead to better outcomes for mothers and babies, like fewer early births, more mothers starting to breastfeed, and higher satisfaction with the birth experience. Doulas also help reduce health differences among different racial groups. ^{1 2 3 4 5}

Is the Doula Model of Care generally safe for perinatal support?

The research articles focus on improving safety in perinatal care through teamwork, communication, and safety culture, but they do not specifically address the safety of the Doula Model of Care. However, they emphasize the importance of a supportive and communicative environment in perinatal settings, which aligns with the principles of doula care. ^{6 7 8 9 10}

How is the Doula Model of Care treatment different from other treatments for perinatal support?

The Doula Model of Care is unique because it provides non-medical support during the perinatal period, focusing on emotional and social support rather than medical interventions. Doulas offer personalized care, advocacy, and education, which can lead to improved maternal and infant outcomes, such as decreased preterm births and increased breastfeeding, and help address racial disparities in health outcomes. ^{2 4 5 11 12}

What is the purpose of this trial?

The goal of this randomized controlled intervention trial is to determine if an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP), will improve both the experience and outcomes for Black birthing people. The main question it aims to answer is whether an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP) will mitigate bias and mistrust thereby improving both the experience and outcomes for Black birthing people, assessed by the primary outcome of depression score. Participants will be randomized to Doula care (receive 2 prenatal visits, continuous intrapartum support, and 2 postpartum visits with a certified doula) or standard of care (receive prenatal care, labor and delivery, and postpartum care as they normally would if not in the study) and followed through 6 weeks postpartum.

Research Team

Sindhu K Srinivas, MD, MSCE

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

Participants must be willing and able to sign the informed consent form

Plan to deliver at HUP

Pregnant patients who self-identify as Black

Exclusion Criteria

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

PI Discretion

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hospital-based maternity care practitioners' perceptions of doulas. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The Doula Model in American Health Care in the 21st Century: A Narrative Literature Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an Innovative, Hospital-Based Volunteer Doula Program. [2020]

4. Scotland pubmed.ncbi.nlm.nih.gov

Cooperation between midwives and doulas in the context of perinatal care - a integrative review of qualitative and quantitative studies. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Doula Care: A Review of Outcomes and Impact on Birth Experience. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of the Agency for Healthcare Research and Quality's Safety Program for Perinatal Care. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Perinatal safety: from concept to nursing practice. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Michigan Health & Hospital Association Keystone Obstetrics: a statewide collaborative for perinatal patient safety in Michigan. [2019]

9. United States 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Patient safety culture in obstetrics and gynecology and neonatology units: the nurses' and the midwives' opinion. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Women's Perceptions of Their Doula Support. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Doulas as community health workers: lessons learned from a volunteer program. [2020]