Melanated Group Midwifery Care for Maternal Care

(MGMC Trial)

Overseen By Kylea L Liese, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: High-risk pregnancy, Cognitive issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

432 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Melanated Group Midwifery Care?

Research shows that Midwifery Group Practice (MGP), a similar model to Melanated Group Midwifery Care, is effective in providing safe, satisfactory, and cost-effective care for women during pregnancy. Studies have demonstrated positive outcomes and high satisfaction levels among women receiving MGP care. ^{1 2 3 4 5}

Is Melanated Group Midwifery Care safe for humans?

Research on midwifery-led care, similar to Melanated Group Midwifery Care, shows it is generally safe for women with low-risk pregnancies, as seen in studies from New Zealand, the Netherlands, and Ireland. ^{3 5 6 7 8}

How is Melanated Group Midwifery Care different from other treatments for maternal care?

Melanated Group Midwifery Care (MGMC) is unique because it offers continuity of care through a small team of midwives, which has been shown to improve maternal and neonatal outcomes and increase women's satisfaction compared to standard hospital care. This model also emphasizes social support and participation in care, which can be particularly beneficial for diverse and vulnerable populations. ^{2 3 5 9 10}

What is the purpose of this trial?

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.

Research Team

Stacie L Geller, PhD

Principal Investigator

University of Illinois Chicago

Eligibility Criteria

This trial is for English-speaking pregnant women who identify as Black, are less than 20 weeks pregnant, and at least 15 years old. They must be new to prenatal care at the University of Chicago Medical Center. Black midwives, care coordinators, and community postpartum doulas from the same center can also join.

Inclusion Criteria

I am 15 years old or older.

Present to the general obstetrics group at the University of Chicago Medical Center for their new prenatal visit

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

Exclusion Criteria

I am able to understand and agree to the study's requirements.

Having a condition for which they present to a higher level of obstetrics care (e.g., maternal fetal medicine) for their new prenatal visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Care

Participants receive prenatal care from a Black midwife in groups with the same 8-10 other Black women throughout pregnancy.

Up to 37 weeks gestation

3 visits (in-person) at baseline, 26-28 weeks, and 35-37 weeks

Postnatal Care

Participants receive postnatal care and support from a postpartum doula and care coordinator.

12 months postpartum

Home visits by doula within first 2 weeks postpartum, ongoing support available

Follow-up

Participants are monitored for patient trust, respect, and engagement through surveys and qualitative interviews.

12 months postpartum

3 survey time points at 2, 6, and 12 months postpartum

Treatment Details

Interventions

• Melanated Group Midwifery Care

Trial Overview The study tests a Melanated Group Midwifery Care model to see if it boosts trust and engagement in Black birthing individuals during maternity care by comparing their experiences with standard practices.

Participant Groups

Group I: MGMC Intervention Group Experimental Treatment 1 Intervention

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 II: Usual Care Active Control 1 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.

Melanated Group Midwifery Care is already approved in United States for the following indications:

Approved in United States as Melanated Group Midwifery Care for:

• Maternity care for Black birthing people

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Findings from Research

Sustaining midwifery group practice (MGP) in Australia requires strong support and value from all stakeholders, including midwives, to ensure long-term success.

The management of MGP is crucial, as it influences how these practices are implemented within the maternity care system, highlighting the need for prioritization and nurturing of midwifery-led models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management and sustainability of midwifery group practice: Thematic and lexical analyses of midwife interviews. Hewitt, L., Dadich, A., Hartz, DL., et al.[2022]

Midwifery Group Practice (MGP) showed significant benefits for Moderate Risk women, with fewer assisted deliveries and labor inductions compared to other care models, indicating a potentially safer and more effective approach.

MGP also resulted in less use of epidural analgesia across all risk categories, suggesting a preference for more natural birthing methods, while maintaining similar safety outcomes in terms of post-partum hemorrhage and neonatal admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of Midwifery Group Practice. Part I: clinical effectiveness. Turnbull, D., Baghurst, P., Collins, C., et al.[2019]

A study involving 120 women enrolled in the Midwifery Group Practice (MGP) model showed a high satisfaction rate, with 70% of participants responding to a satisfaction questionnaire.

Key themes of satisfaction included continuity of care, accessibility, and the personal and professional qualities of midwives, indicating that women valued the personalized and consistent support they received during their pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of Midwifery Group Practice. Part II: women's satisfaction. Fereday, J., Collins, C., Turnbull, D., et al.[2019]

A study analyzing 337 women in a Midwifery Group Practice (MGP) over 12 months found that 50% of cases were discussed collaboratively between obstetricians and midwives, with a high adherence to care plans (90%) and guidelines (85%).

The collaborative model of care resulted in high professional satisfaction among both midwives and obstetricians, demonstrating its effectiveness for managing women of all risk levels in maternity care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration in maternity care is achievable and practical. Beasley, S., Ford, N., Tracy, SK., et al.[2012]

In a study of 232 women in a midwifery group practice (MGP) at a Western Australian hospital, 87% achieved vaginal births, which is significantly higher than the 65% rate in the general WA population, indicating the efficacy of the MGP model.

Women in the MGP reported high satisfaction, with 98% recommending the service, and they experienced lower rates of epidural use (34% vs 59%) and cesarean sections (13% vs 35%), suggesting that MGP is a safe and acceptable alternative to traditional maternity care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of the first 'no exit' midwifery group practice in a tertiary maternity hospital in Western Australia: Outcomes, satisfaction and perceptions of care. Lewis, L., Hauck, YL., Crichton, C., et al.[2018]

In a study of 244,047 singleton, term deliveries in New Zealand, medical-led maternity care was associated with significantly lower odds of adverse perinatal outcomes, such as low Apgar scores and birth-related asphyxia, compared to midwife-led care.

Despite the benefits of midwife-led care, such as higher patient satisfaction, the study found an unexplained excess of adverse events in midwife-led deliveries, indicating a need for further investigation into the safety and outcomes of this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Midwife-Led and Medical-Led Models of Care and Their Relationship to Adverse Fetal and Neonatal Outcomes: A Retrospective Cohort Study in New Zealand. Wernham, E., Gurney, J., Stanley, J., et al.[2019]

In a study of 1,000 patient records from midwifery practices in the Netherlands, a low incidence of safety incidents (8.6%) was found among low-risk pregnant women, with only 25 incidents having a noticeable effect on patients, and no incidents leading to mortality or permanent harm.

The majority of safety incidents were related to treatment and organizational factors, highlighting the need for improvements in adherence to practice guidelines, risk assessment, and midwife availability during birthing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in midwifery-led care in the Netherlands. Martijn, LL., Jacobs, AJ., Maassen, II., et al.[2022]

Midwife-led maternity care is safe for low-risk women, as shown by a study of 3,884 women over six years, with a low transfer rate of 14.6% during labor and minimal complications.

The study found that midwife-led units (MLUs) had higher rates of spontaneous vaginal births (98.7%) and fewer interventions like episiotomies and amniotomies compared to consultant-led care, suggesting a more natural birthing experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midwife-led maternity care in Ireland - a retrospective cohort study. Dencker, A., Smith, V., McCann, C., et al.[2019]

The GC_1000 project aims to develop and share effective strategies for implementing group care in maternity services, focusing on vulnerable populations and improving their health outcomes.

Over four years, the project will analyze the implementation of group care in seven countries, using a structured framework to ensure that the findings are applicable and sustainable across different health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Care in the first 1000 days: implementation and process evaluation of contextually adapted antenatal and postnatal group care targeting diverse vulnerable populations in high-, middle- and low-resource settings. Martens, N., Crone, MR., Hindori-Mohangoo, A., et al.[2022]

Infants of mothers who received midwifery group practice (MGP) care during pregnancy showed better neurodevelopmental outcomes at 6 months, particularly in fine motor and problem-solving skills, compared to those whose mothers received standard hospital care (SC).

Even when accounting for maternal stress due to a natural disaster, the MGP model was associated with a lower risk of developmental delays in infants, highlighting the importance of continuity in midwifery care for improving infant outcomes in stressful situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disaster in pregnancy: midwifery continuity positively impacts infant neurodevelopment, QF2011 study. Simcock, G., Kildea, S., Kruske, S., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Management and sustainability of midwifery group practice: Thematic and lexical analyses of midwife interviews. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

An evaluation of Midwifery Group Practice. Part I: clinical effectiveness. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

An evaluation of Midwifery Group Practice. Part II: women's satisfaction. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

Collaboration in maternity care is achievable and practical. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

An overview of the first 'no exit' midwifery group practice in a tertiary maternity hospital in Western Australia: Outcomes, satisfaction and perceptions of care. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Midwife-Led and Medical-Led Models of Care and Their Relationship to Adverse Fetal and Neonatal Outcomes: A Retrospective Cohort Study in New Zealand. [2019]

7. Scotland pubmed.ncbi.nlm.nih.gov

Patient safety in midwifery-led care in the Netherlands. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Midwife-led maternity care in Ireland - a retrospective cohort study. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Group Care in the first 1000 days: implementation and process evaluation of contextually adapted antenatal and postnatal group care targeting diverse vulnerable populations in high-, middle- and low-resource settings. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Disaster in pregnancy: midwifery continuity positively impacts infant neurodevelopment, QF2011 study. [2023]