Clinical trial NCT05365815: Melanated Group Midwifery Care (MGMC)
Official title: Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Complications
Maternal Care Patterns
Patient Engagement
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Chicago
First posted: 2022-05-09
Enrollment: 432
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Engagement-Prenatal Adequacy
timeFrame: Birth (T3)
measure: Patient Engagement-Prenatal Adherence
timeFrame: Birth (T3)
measure: Patient Engagement-Postnatal adequacy
timeFrame: 1 year postpartum (T6)
Secondary outcomes:
measure: Patient activation
timeFrame: Change from baseline through 12 months postpartum (T6)
measure: Patient Autonomy
timeFrame: Change from baseline through 12 months postpartum (T6)
measure: Provider Trust
timeFrame: Change from baseline through 12 months postpartum (T6)
measure: Patient Satisfaction
timeFrame: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
measure: Mental Well Being
timeFrame: Change from baseline through 12 months postpartum (T6)
measure: Respectful Care
timeFrame: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
Other outcomes:
measure: Medical Referrals
timeFrame: 12 months postpartum (T6)
measure: Social Referrals
timeFrame: 12 months postpartum (T^)
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Stacie L Geller, PhD
role: PRINCIPAL_INVESTIGATOR
References: