Recruiting

MGMC

Sponsor:

University of Illinois at Chicago

Code:

NCT05365815

Conditions

Pregnancy Complications

Maternal Care Patterns

Patient Engagement

Eligibility Criteria

Sex: Female

Age: 15 - 49

Healthy Volunteers: Accepted

Interventions

Melanated Group Midwifery Care

Study Details

Brief summary:

This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.

Conditions

Pregnancy Complications

Maternal Care Patterns

Patient Engagement

Study ID

NCT05365815

Start date

Jun 8, 2022

Status verified date

Jul, 2024

Completion date

Feb 1, 2027

Anticipated

Primary completion date

May 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 49

Healthy Volunteers: Accepted

Inclusion criteria for patients:

  • pregnant women who self-identify as Black on a standard prenatal intake form
  • less than 20 weeks pregnant
  • 15 years old or older
  • present to the general obstetrics group at the University of Chicago Medical Center for their new prenatal visit
  • speak and understand English

Inclusion criteria for providers:

• All black midwives, care coordinators, and community postpartum doulas at the University of Chicago are eligible to participate.

Exclusion criteria for patients:

  • having a condition for which they present to a higher level of obstetrics care (e.g., maternal fetal medicine) for their new prenatal visit
  • having a cognitive issue that impairs their ability to give informed consent.

Study Design

Enrollment

432 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: MGMC Intervention Group

In the MGMC (intervention) group, pregnant women will participate in group prenatal care and have \~2-hour visits with the same two co-facilitators, a Black midwife and a Black care coordinator, along with 8-12 other Black women at a similar stage of pregnancy, for all prenatal and one postnatal care visits.

The care coordinator will proactively engage with women throughout pregnancy and up to 12 months postpartum. The care coordinator helps women make appointments, sends reminders, and follows-up to ensure care was received, understood, and was appropriate. In the 3rd trimester, women in MGMC will be introduced to a community-based postpartum doula. The doula will make home visits once before birth and within the first 2 weeks postpartum; they will have approximately 50 contact hours available for 12 months postpartum for primarily in-person support, but they will be available by phone and text.

no intervention: Usual Care

In the usual care (comparator) group, pregnant women attend individually scheduled visits with a midwife or obstetrician for a physical assessment and counseling. Although this can vary by provider, continuity of care is rare and racial concordance is not a consideration. Referrals for medical or social services are given to the patient to complete in both prenatal and postnatal care.

Interventions

Melanated Group Midwifery Care

Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support

Primary outcome measure

  • Patient Engagement-Prenatal Adequacy [ Time Frame: Birth (T3) ]
  • Patient Engagement-Prenatal Adherence [ Time Frame: Birth (T3) ]
  • Patient Engagement-Postnatal adequacy [ Time Frame: 1 year postpartum (T6) ]

Central Contacts and Locations

Central contacts

Kylea L Liese, PhD

3129961867kylea3@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612-7316

Contacts

Kylea L Liese, PhD

312-996-1867kylea3@uic.edu

Stacie Geller, PhD

sgeller@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 3, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2024-07-03.