Doula Partnership for Pregnancy

(BUNDLE Trial)

Overseen By Joni S Williams, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Non-Froedtert delivery, Group care, others

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

Compensation: Varies

Number of Visits: 6

412 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the integration of community doulas into prenatal care to improve trust and health outcomes for Black/African American expecting mothers. It includes focus groups to gather feedback and tests a new care model where doulas and obstetricians collaborate. Specifically, the trial examines whether having a doula present during certain prenatal visits and labor can enhance care and support. Pregnant Black or African American women expecting one baby, who already have an OBGYN at Froedtert & the Medical College of Wisconsin, are ideal candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative care models that could transform prenatal experiences.

Do I need to stop 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 healthcare provider.

What prior data suggests that this model is safe for prenatal care?

Research has shown that including doulas in maternity care can lead to safer and more positive experiences for mothers. One study found that women supported by a doula were less likely to have a cesarean delivery and less likely to experience postpartum depression. This suggests that doulas in maternity care could benefit mothers' health. No specific negative effects have been reported from having a doula. Overall, evidence suggests that doula care is a well-accepted and effective way to support mothers before and after birth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Doula Partnership for Pregnancy trial because it explores the potential benefits of integrating doula support into prenatal care, which isn't typically part of standard care. Unlike usual care, which mainly involves clinical visits and standard medical support, this approach includes personalized support from a doula who attends important prenatal visits and works closely with the medical team to identify and address social and clinical risk factors. This collaboration aims to enhance communication between patients and providers and prepare the labor team for the presence of a doula during delivery, offering additional emotional and physical support. By potentially reducing cardiovascular risks postpartum and improving overall pregnancy outcomes, this intervention could offer a more holistic and supportive experience for expectant mothers.

What evidence suggests that the BUNDLE intervention is effective for improving maternal health outcomes?

This trial will compare the BUNDLE intervention, which includes doula support, with usual care. Research has shown that including a doula in prenatal care can improve maternal health, particularly in communities facing more challenges. Studies have found that doula support during pregnancy leads to better health outcomes for mothers, including fewer complications during labor and birth. Doulas offer emotional and physical support, reducing stress and fostering trust between mothers and healthcare providers. Evidence also suggests that doulas enhance the childbirth experience, making it more satisfying. Overall, doulas contribute to a more positive and supportive environment for expecting mothers. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

The BUNDLE study is for Black or African American individuals who are pregnant with one baby and already have an OB-GYN at Froedtert & the Medical College of Wisconsin Health System. It aims to improve trust and maternal health outcomes.

Inclusion Criteria

You have identified yourself as Black or African American.

You are pregnant with a single fetus.

You have a registered OBGYN at the Froedtert & Medical College of Wisconsin Health System.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Phase

Conducting focus groups with Black/African American birthing people and healthcare providers to integrate community-based doulas and obstetricians into prenatal care

Not specified

6 focus groups

Randomized Controlled Trial

Testing the effectiveness of the integrated prenatal care model on healthcare engagement, trust, and adverse maternal outcomes

From study enrollment until 12 months postpartum

Multiple visits throughout pregnancy and postpartum

Dissemination

Disseminating findings in scholarly and community-based forums and advocating for policy changes

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• BUNDLE

Trial Overview

This study tests a new model that integrates community-based doulas into prenatal care. Participants will either receive usual care or be part of the BUNDLE intervention, which includes doula support, to see if it improves healthcare engagement and reduces adverse outcomes.

How Is the Trial Designed?

Group I: BUNDLE Intervention Experimental Treatment 1 Intervention

Proposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction.

Group II: Usual Care Active Control 1 Intervention

Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

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

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

The use of doulas appears an effective strategy for improving maternal health, especially among socioeconomically vulnerable and marginalized minority ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12506227/

Effectiveness and evidence-based practices in maternal ...

The primary outcomes that will be extracted and reported are maternal outcomes related to labour and delivery (pregnancy and labour ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05993689

Building TrUst and UNiting Teams Through DouLa ...

The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The investigators will pursue the ...

4.

saferbirth.org

saferbirth.org/patient-safety-bundles/

Patient Safety Bundles For Safer Birth | AIM

Patient Safety Bundles are a structured way of improving the processes of care and patient outcomes. Patient safety bundles are collections of ...

5.

bmcpregnancychildbirth.biomedcentral.com

bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-05987-7

Comparison of maternal outcomes in caring by Doula, trained ...

The aim of this study was to compare maternal and neonatal outcomes in the care provided by Doula, trained lay companion, and routine midwifery ...

6.

cms.gov

cms.gov/priorities/innovation/innovation-models/transforming-maternal-health-tmah-model

Transforming Maternal Health (TMaH) Model

These evidence-informed interventions are called “patient safety bundles.” When implemented together and consistently, these protocols are shown to improve ...