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Community Doula Support for Pregnancy

N/A
Recruiting
Led By Melissa A Simon, MD, MPH
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1) Pregnant individuals that are age 15-49 years; (2) uninsured or have public insurance (i.e., Medicaid); (3) singleton pregnancy <32 weeks gestation; and (4) not cognitively impaired
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 1 year postpartum
Awards & highlights

Study Summary

This trial will test an intervention to help pregnant women get better perinatal care, by using a checklist with the help of a Community Doula Navigator.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-medical intervention through support and checklists rather than drugs or medical procedures, there are no typical side effects like those seen in drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 1 year postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 1 year postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Recommended Perinatal Care Components Received
Secondary outcome measures
Level of patient engagement in healthcare management
Level of self-efficacy for dealing with stressful situations
Level of trust in health care system
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard Care with Well-Mama InterventionExperimental Treatment1 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 CareActive Control1 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.

Find a Location

Who is running the clinical trial?

Cook County Health & Hospitals SystemOTHER
6 Previous Clinical Trials
4,274 Total Patients Enrolled
Woman's Hospital, LouisianaOTHER
3 Previous Clinical Trials
940 Total Patients Enrolled
Rutgers UniversityOTHER
113 Previous Clinical Trials
2,803,517 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study permit participants aged eighteen or older?

"Patients of this trial must be between 15 and 49 years old."

Answered by AI

Do I qualify to join this scientific research?

"This research endeavour seeks to enroll 576 pregnant women aged between 15 and 49. To be eligible, a female must: (1) Be in the specified age range; (2) Possess public insurance or lack medical coverage altogether; (3) Have a singleton pregnancy no greater than 32 weeks gestation; and (4) Not suffer from cognitive impairment."

Answered by AI

Are there any limitations to the number of participants in this clinical trial?

"Indeed, the information hosted on clinicaltrials.gov reveals that this medical experiment is currently accepting volunteers. Initially advertised on May 7th 2023 and most recently updated on November 9th 2023, they are looking for a total of 576 individuals at 2 different facilities."

Answered by AI

Are new participants being admitted to this trial at present?

"Clinicaltrials.gov confirms that this research study is presently recruiting volunteers; the original posting date was May 7th 2023 and it has been modified as recently as November 9th 2023."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Well-Mama Community Doula Navigator Study
Melissa Simon 2023. "Well-Mama Community Doula Navigator Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05179369.
~372 spots leftby Dec 2025
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