Community Doula Support for Pregnancy

Recruiting at 1 trial location

Overseen By Anastasia Harris, MPH, CHES

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Group prenatal care, others

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

Compensation: Varies

Number of Visits: 1

576 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the Well-Mama intervention, a program designed to support pregnant women with the help of Community Doula Navigators. Participants will receive either usual prenatal and postpartum care or the same care plus additional support from the Well-Mama intervention, which includes a checklist, a doula, and virtual support groups. The trial aims to determine if this extra support improves the pregnancy experience. It is suitable for pregnant individuals with a single baby who are less than 32 weeks along and either uninsured or on Medicaid. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance prenatal care for many.

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 Well-Mama Intervention is safe for pregnant women?

Research has shown that having a doula, a key component of the Well-Mama program, leads to better outcomes for mothers and babies, including fewer early births and other health benefits.

The Well-Mama program features Community Doula Navigators who provide guidance and support during pregnancy. While specific safety data for this program is not available, doula support is generally considered safe and beneficial. The program emphasizes help and support rather than medical treatment, typically resulting in fewer risks.

Overall, the Well-Mama program aims to enhance standard care and is not expected to present significant safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Well-Mama Intervention because it adds a personal touch to pregnancy care that isn't typically found in standard options. While most prenatal care focuses on regular check-ups and medical assessments, this intervention includes a Community Doula Navigator and virtual support groups, which aim to provide emotional and social support throughout the pregnancy journey. This holistic approach could improve maternal well-being by addressing not just physical but also emotional needs, making the experience more supportive and connected.

What evidence suggests that the Well-Mama Intervention is effective for supporting pregnant women?

Studies have shown that having a doula, like those in the Well-Mama program, can lead to better birth outcomes. Specifically, research has found that doula support is linked to fewer C-sections. In this trial, participants in the "Standard Care with Well-Mama Intervention" arm will receive the Well-Mama program, which uses Community Doula Navigators and checklists to ensure pregnant women receive comprehensive care before and after birth. This support increases the likelihood of attending important medical appointments and following care guidelines. Early findings suggest that this kind of support can improve the overall health of both mothers and babies. ^{1 3 5 6 7}

Who Is on the Research Team?

Melissa A Simon, MD, MPH

Principal Investigator

Center for Health Equity Transformation Northwestern University

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 15-49, uninsured or on Medicaid, with a single baby pregnancy under 32 weeks. They must not have cognitive impairments to participate.

Inclusion Criteria

1) You are pregnant and between 15 and 49 years old; 2) you do not have private insurance (like Medicaid); 3) you are less than 32 weeks pregnant with one baby; and 4) you do not have cognitive impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Care

Participants receive standard prenatal care, with monthly visits for the first 28 weeks, biweekly visits for weeks 28-36, and weekly visits after 36 weeks. Additional support includes nutritional counseling and childbirth education.

Up to 40 weeks

Monthly, biweekly, and weekly visits

Well-Mama Intervention

Participants receive the Well-Mama intervention, including the Well Mama Checklist, assistance from a Community Doula Navigator, and virtual support groups.

Throughout pregnancy and postpartum

In-person and telehealth check-ins

Postpartum Care

Participants receive a comprehensive postpartum care visit within the first 6 weeks of birth, involving a physical examination, lab tests, and immunizations.

6 weeks

1 comprehensive visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys measuring engagement, self-efficacy, trust, and experiences of racism and discrimination.

1 year postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Well-Mama Intervention

Trial Overview The study is testing the Well-Mama intervention which uses a checklist by Community Doula Navigators to support pregnant women, compared to standard perinatal care alone.

How Is the Trial Designed?

Group I: Standard Care with Well-Mama Intervention Experimental Treatment 1 Intervention

Participants will receive standard perinatal care plus the Well Mama intervention, including the Well Mama Checklist, assistance from a Community Doula Navigator, and virtual support groups.

Group II: Standard Care Active Control 1 Intervention

Participants randomized to standard care will be offered prenatal and postpartum care in accordance with site-specific procedures based on AAP and ACOG Guidelines for Perinatal Care. The initial intake appointment, involving a comprehensive visit with physical exam, medical and psychosocial history, laboratory testing, and education would optimally occur in the 1st trimester. Subsequent prenatal visits, per ACOG, is monthly for the first 28 weeks, biweekly for weeks 28-36, and weekly after 36 weeks. More frequent visits may be offered to women at high risk. In addition, some sites may offer supports such as nutritional counseling, childbirth education, and case management. A comprehensive postpartum care visit would typically occur within the first 6 weeks of birth, involving a physical examination, lab tests, and immunizations.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Cook County Health & Hospitals System

Collaborator

Trials

7

Recruited

2,910,000+

Woman's Hospital, Louisiana

Collaborator

Trials

4

Recruited

1,200+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Published Research Related to This Trial

Women in racial and ethnic minority groups, particularly those from lower-income backgrounds, generally have positive perceptions of doula services and may benefit significantly from hospital-based doula programs.

The study highlights the need for doula training and services to be adapted to meet the specific needs of diverse populations, including those with substance use disorders and younger mothers, to effectively address gaps in maternal health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Perspectives on the Creation of a Hospital-Based Doula Program. Attanasio, LB., DaCosta, M., Kleppel, R., et al.[2021]

Community doulas at SisterWeb San Francisco spend about half of their time providing direct client care, but they also dedicate significant time (2.15 hours for every hour of direct care) to communication and support activities, highlighting their extensive role in pregnancy and postpartum support.

The study emphasizes the need for recognition and appropriate compensation for the diverse activities community doulas engage in, as this is crucial for promoting health equity in maternal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What, when, and how long? Doula time use in a community doula program in San Francisco, California. Arcara, J., Cuentos, A., Abdallah, O., 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]

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 study successfully recruited 39 mothers with depressive symptoms, 6 postpartum doulas, and 6 peer telephone supporters, indicating that it is feasible to conduct research on postpartum support interventions.

Mothers who received support from postpartum doulas reported higher satisfaction compared to those who received peer telephone support, suggesting that doula support may be more beneficial for mothers experiencing postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. Gjerdingen, DK., McGovern, P., Pratt, R., et al.[2022]

Participation in the By My Side Birth Support Program was linked to significantly lower odds of preterm birth (5.6% vs 11.9%) and low birthweight (5.8% vs 9.7%) among participants, indicating improved birth outcomes.

The program, which provides community-based doula support, highlights the potential of doula services to address birth inequities, particularly for Black and Hispanic populations, without affecting cesarean delivery rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Birth equity on the front lines: Impact of a community-based doula program in Brooklyn, NY. Thomas, MP., Ammann, G., Onyebeke, C., et al.[2023]

The doula-home-visiting program significantly increased attendance in childbirth-preparation classes and improved infant-care behaviors, such as placing infants on their backs to sleep and using car seats, compared to standard case management.

Mothers in the intervention group were less likely to use epidurals or pain medication during labor and more likely to initiate breastfeeding, although the latter effect did not last over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Hans, SL., Edwards, RC., Zhang, Y.[2019]

This randomized controlled trial aims to evaluate the effectiveness of community-based doulas (CBDs) in improving the childbirth experiences and postnatal well-being of 200 migrant women in Sweden, addressing issues like communication barriers and feelings of fear and isolation during labor.

The study will assess the impact of CBD support on women's ratings of care and postnatal mental health, using validated questionnaires, with results expected to inform better maternity care practices for migrant populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640). Schytt, E., Wahlberg, A., Eltayb, A., et al.[2021]

Citations

1. labs.feinberg.northwestern.edu labs.feinberg.northwestern.edu/elevate/research/projects/wellmama-doula.html

Well-Mama Doula Project - Feinberg Labs A randomized trial is underway in Chicago, Newark and Baton Rouge to evaluate the impact of the Well-Mama program on patient receipt of comprehensive prenatal ...

2. withpower.com withpower.com/trial/phase-4-2022-ae29d

Community Doula Support for Pregnancy This study will develop and test an intervention, called the Well-Mama intervention, which includes the use of a checklist by Community Doula Navigators to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05179369

Well-Mama Community Doula Navigator Study The investigators will conduct a randomized trial to test whether the Well-Mama intervention increases BIPOC women's receipt of prenatal and postpartum care.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05179369/well-mama-community-doula-navigator-study

Well-Mama Community Doula Navigator Study This study will develop a Well-Mama intervention for pregnant and postpartum BIPOC women, centered around Community Doula Navigators conducting ...

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

The Effect of Doulas on Maternal and Birth Outcomes The studies in this review indicated that doula guidance in perinatal care was associated with positive delivery outcomes including reduced cesarean sections.

6. trialx.com trialx.com/clinical-trials/listings/251230/well-mama-community-doula-navigator-study/

Well-Mama Community Doula Navigator Study This study will develop a Well-Mama intervention for pregnant and postpartum BIPOC women, centered around Community Doula Navigators conducting ...

7. reporter.nih.gov reporter.nih.gov/search/14EACD094D84C7D77598B8961CAA4A01A2FFCEB861BF/project-details/11083749

Project Details - NIH RePORTER This study will develop a Well-Mama intervention for pregnant and postpartum Black and Hispanic women, centered around Community Doula Navigators conducting in- ...