Melanated Group Midwifery Care (MGMC)

NCT05365815 | Recruiting

• 2 other identifiers: CHAIRb 21120101AD-2020C3-21229
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Patient Engagement-Prenatal Adequacy

  Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records

  Birth (T3)

• Patient Engagement-Prenatal Adherence

  Five tests completed during prenatal period (yes/no), documented in electronic medical record

  Birth (T3)

• Patient Engagement-Postnatal adequacy

  Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record

  1 year postpartum (T6)

Secondary Outcomes (6)

• Patient activation

  Change from baseline through 12 months postpartum (T6)

• Patient Autonomy

  Change from baseline through 12 months postpartum (T6)

• Provider Trust

  Change from baseline through 12 months postpartum (T6)

• Patient Satisfaction

  Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)

• Mental Well Being

  Change from baseline through 12 months postpartum (T6)

Other Outcomes (2)

• Medical Referrals

  12 months postpartum (T6)

• Social Referrals

  12 months postpartum (T^)

Study Arms (2)

MGMC Intervention Group

EXPERIMENTAL

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.

Behavioral: Melanated Group Midwifery Care

Usual Care

NO INTERVENTION

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 BEHAVIORAL

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

MGMC Intervention Group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pregnant women who self-identify as Black on a standard prenatal intake form
• less than 20 weeks pregnant
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Chicago: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612-7316, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Patient Participation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Stacie L Geller, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kylea L Liese, PhD

CONTACT

3129961867; kylea3@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research team working on the effectiveness evaluation of group care is blinded to study condition and is charged with collecting the Aim 1 effectiveness data from the individuals.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 9, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)