Melanated Group Midwifery Care (MGMC)

NCT ID: NCT05365815

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2027-02-01

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.

Detailed Description

Low-risk pregnant participants will be randomized into Melanated Group Midwifery Care or usual individualized obstetric care. In Melanated Group Midwifery Care (MGMC), Black women will receive prenatal care from a Black midwife in groups with the same 8-10 other Black women throughout pregnancy. In pregnancy and into the first year postpartum, MGMC patients will stay connected to the health system through a proactive care coordinator, who is a Black licensed nurse. For the first year after giving birth, patients in MGMC will also be supported by a trained postpartum doula.

All participants (intervention and usual care groups) will complete study measures that include validated surveys on patient trust, respect and engagement at 6 time points:

• 3 time points in pregnancy [baseline (<20 weeks), 26-28 weeks, and 35- 37 weeks] and
• 3 in the postpartum at 2-, 6-, and 12-months
• Additional qualitative interviews will be done to track the care received by medically and socially complex patients, including all who experience a severe maternal morbidity.

The investigators will also document how MGMC gets embedded in practice through a qualitative process evaluation.

Conditions

Pregnancy Complications; Maternal Care Patterns; Patient Engagement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Melanated Group Midwifery Care

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Melanated Group Midwifery Care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Kylea Laina Liese

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stacie L Geller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kylea L Liese, PhD

Role: CONTACT

kylea3@uic.edu

3129961867

Facility Contacts

Kylea L Liese, PhD

Role: primary

kylea3@uic.edu

312-996-1867

Stacie Geller, PhD

Role: backup

sgeller@uic.edu

Other Identifiers

AD-2020C3-21229

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CHAIRb 21120101

Identifier Type: -

Identifier Source: org_study_id