Melanated Group Midwifery Care (MGMC)

Pregnancy Complications Clinical Trial

— MGMC  

Official title:

Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365815
• Other study ID #: CHAIRb 21120101
• Secondary ID: AD-2020C3-21229
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: February 1, 2027

Study information

• Verified date: May 2023
• Source: University of Illinois at Chicago
• Contact: Kylea L Liese, PhD
• Phone: 3129961867
• Email: kylea3[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: February 1, 2027
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Care Patterns
• Patient Engagement
• Pregnancy Complications

Intervention

Behavioral:
• Melanated Group Midwifery Care
Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Patient-Centered Outcomes Research Institute, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical Referrals	Referrals to higher acuity medical or obstetric care	12 months postpartum (T6)
Other	Social Referrals	Referrals to higher acuity mental health or social services	12 months postpartum (T^)
Primary	Patient Engagement-Prenatal Adequacy	Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records	Birth (T3)
Primary	Patient Engagement-Prenatal Adherence	Five tests completed during prenatal period (yes/no), documented in electronic medical record	Birth (T3)
Primary	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	Patient activation	Patient Activation Measure (PAM), 13-item scale, range 0-100, Likert disagree strongly to agree strongly and not applicable. Assesses degree to which individuals take an active role in managing health and health care. Higher scores are more likely to understand that their active involvement is critical to their state of health and considered more ''in charge.'' The PAM has strong psychometric properties and is predictive of a wide range of health-related behaviors. Hibbard et al. report that a 4-point difference in PAM scores can be viewed as clinically significant.	Change from baseline through 12 months postpartum (T6)
Secondary	Patient Autonomy	Mothers Autonomy in Decision-Making Scale. 7 item scale, Likert completely disagree to completely agree. Assesses the degree to which patients were given decision-making for healthcare decisions, and if patients felt respected by providers. Higher scores indicate that providers supported patient autonomy and patient decision-making.	Change from baseline through 12 months postpartum (T6)
Secondary	Provider Trust	Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; a =0.85-0.90.	Change from baseline through 12 months postpartum (T6)
Secondary	Patient Satisfaction	22 items; 5-point Likert (excellent to poor); a =0.95. Excellent reliability and construct validity, taps six established dimensions of satisfaction (art of care, technical quality, access, physical environment, availability, and efficacy)	Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
Secondary	Mental Well Being	Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health.	Change from baseline through 12 months postpartum (T6)
Secondary	Respectful Care	Mothers on Respect index (MORi) quantifies women's sense of disrespect and dismissal when engaging in conversation with providers, 14 items, Likert, ranging from 1-strongly disagree to 6-strongly agree. a =0.94	Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)