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

Trial Summary

What is the purpose of this trial?

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 support pregnant women. Participants will be randomized to either receive standard perinatal care or standard perinatal care plus the Well-Mama intervention.

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 treatment Well-Mama Intervention, Well-Mama Community Doula Navigator Intervention, Well-Mama Support Program?

Research shows that doula support, which is part of the Well-Mama interventions, is linked to better outcomes for mothers and babies, like fewer early births, more breastfeeding, and higher satisfaction. Doulas also help reduce health differences among racial groups, making this support especially helpful for communities with higher health risks. ^{1 2 3 4 5}

Is community doula support safe for pregnant women?

Research shows that community doula support is generally safe and is associated with positive outcomes like decreased preterm birth and increased breastfeeding initiation. It also helps improve maternal and infant health, especially in diverse communities. ^{1 2 4 6 7}

How is the Well-Mama Intervention treatment different from other treatments for pregnancy support?

The Well-Mama Intervention is unique because it involves community doulas who provide culturally appropriate, nonclinical support during and after pregnancy, focusing on emotional and physical assistance at low or no cost. This approach is distinct from traditional medical treatments as it emphasizes birth equity and informed decision-making, particularly benefiting low-resource, high-need patients. ^{1 2 3 6 8}

Research Team

Melissa A Simon, MD, MPH

Principal Investigator

Center for Health Equity Transformation Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

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

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

Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. [2022]

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

Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. [2019]

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

Community Perspectives on the Creation of a Hospital-Based Doula Program. [2021]

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

Birth equity on the front lines: Impact of a community-based doula program in Brooklyn, NY. [2023]

7. England 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). [2021]

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

What, when, and how long? Doula time use in a community doula program in San Francisco, California. [2023]