Pregnancy ComplicationsMGMCNCT05365815
Melanated Group Midwifery Care (MGMC)
A study testing Melanated Group Midwifery Care in people with Pregnancy Complications and Maternal Care Patterns, run by University of Illinois at Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Maternal Care Patterns, Patient Engagement
- What is being tested?
- Melanated Group Midwifery Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 1 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612-7316
About this study
Official title: Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism
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.
Read the 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.
- Being tested
- Melanated Group Midwifery Care
- Medical subject headings
- Pregnancy Complications, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanated Group Midwifery CareBehavioural
Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Engagement-Prenatal Adequacy
Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records
Measured: Birth (T3)
Patient Engagement-Prenatal Adherence
Five tests completed during prenatal period (yes/no), documented in electronic medical record
Measured: Birth (T3)
Patient Engagement-Postnatal adequacy
Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record
Measured: 1 year postpartum (T6)
Secondary outcomes (6)
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.
Measured: Change from baseline through 12 months postpartum (T6)
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.
Measured: Change from baseline through 12 months postpartum (T6)
Provider Trust
Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; α =0.85-0.90.
Measured: Change from baseline through 12 months postpartum (T6)
Patient Satisfaction
22 items; 5-point Likert (excellent to poor); α =0.95. Excellent reliability and construct validity, taps six established dimensions of satisfaction (art of care, technical quality, access, physical environment, availability, and efficacy)
Measured: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
Mental Well Being
Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health.
Measured: Change from baseline through 12 months postpartum (T6)
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. α =0.94
Measured: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start8 Jun 2022
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Chicago
- Responsible party
- Principal investigator, Kylea Laina Liese, University of Illinois at Chicago
- Investigators
- Stacie L Geller, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365815
- Sponsor's protocol ID
- CHAIRb 21120101
- Other IDs
- AD-2020C3-21229
- Acronym
- MGMC
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No