Group-Based Prenatal Care for Preventing Premature Birth

Overseen By Britni L Ayers, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Must not be taking: Glucocorticoids, Insulin, Thyroid hormones

Disqualifiers: Fertility treatments, High-risk pregnancy, others

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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if group-based prenatal care, such as Centering Pregnancy with Care Navigation, can improve pregnancy outcomes for Marshallese women in the US. The focus includes reducing premature births and low-birth weight infants, while also examining factors like cesarean deliveries and emergency visits. Participants will either join this group-based care with additional support or continue with standard prenatal care for comparison. Marshallese women who are pregnant (12-14 weeks along), not using fertility treatments, and not expecting multiple babies may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance prenatal care for Marshallese women.

Will I have to stop taking my current medications?

The trial requires that you do not use medications known to influence fetal growth, such as glucocorticoids, insulin, or thyroid hormones.

What prior data suggests that group-based prenatal care with care navigation is safe for pregnant women?

Research shows that group-based prenatal care programs, such as Centering Pregnancy, are generally safe and well-received. Past studies have found these programs improve outcomes without major safety issues. The Centering Pregnancy model includes group sessions where pregnant women receive care and support together, which has been linked to fewer early births and higher patient satisfaction.

Adding care navigation, which guides patients through their prenatal journey, has been particularly helpful for women who often miss appointments. This approach has shown promise in reducing problems like early births. While no treatment is completely without risk, studies reviewed have not linked the combination of group care and navigation to significant negative effects.

Overall, current evidence suggests that this treatment is safe for expectant mothers, especially when compared to standard care alone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of Centering Pregnancy with Care Navigation because it offers a fresh approach to prenatal care for preventing premature births, particularly among pregnant Marshallese women. Unlike traditional prenatal care, which typically involves individual appointments, this method emphasizes group-based care, fostering community support and shared learning among expectant mothers. Additionally, the inclusion of care navigation aims to address barriers to accessing healthcare, potentially improving both maternal and infant health outcomes. By integrating these elements, the trial hopes to demonstrate not only the feasibility of this model but also its potential effectiveness compared to standard practices.

What evidence suggests that Centering Pregnancy with Care Navigation is effective for preventing premature birth?

Research has shown that Centering Pregnancy with Care Navigation, which participants in this trial may receive, can lead to better pregnancy outcomes. Studies have found that this approach reduces the chances of early births and perinatal deaths compared to traditional care. It also improves access to prenatal care, benefiting both mother and baby. The program includes group sessions where women receive care and learn from each other, fostering a strong support network. This supportive environment is linked to better health for both mothers and their babies. Overall, Centering Pregnancy with Care Navigation appears to make pregnancy safer and healthier. ^{1 6 7 8 9}

Who Is on the Research Team?

Britni L Ayers, PhD

Principal Investigator

University of Arkansas for Medical Sciences Northwest

Are You a Good Fit for This Trial?

This trial is for pregnant Marshallese women, aged 18 or older, who are in their first trimester (12-14 weeks gestation). It's not open to those who used fertility treatments, have a high-risk pregnancy requiring special care, are expecting multiple babies, or take medications that affect fetal growth.

Inclusion Criteria

I am currently 12-14 weeks pregnant.

Women who self-report as Marshallese

Exclusion Criteria

I am not taking medications that can affect fetal growth.

High-risk pregnancy that requires a transfer to a high-risk clinic

Conception with the use of fertility treatments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants engage in the Centering Pregnancy program with care navigation to improve prenatal care attendance and maternal health outcomes.

Throughout pregnancy

Regular group sessions

Postpartum Follow-up

Participants' maternal and infant health records are collected and assessed for outcomes such as caesarean delivery, low birthweight, and preterm birth.

6 weeks postpartum

1 visit (in-person)

Social Support Assessment

Assessment of participants' enrollment in social services with a bilingual Marshallese care navigator.

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Centering Pregnancy with Care Navigation

Trial Overview The study tests 'Centering Pregnancy with Care Navigation' against standard prenatal care. It aims to see if this group-based program can improve attendance at care appointments and outcomes like preterm birth rates and infant weight.

How Is the Trial Designed?

Group I: Centering Pregnancy with Care Navigation for pregnant Marshallese women Experimental Treatment 1 Intervention

Forty pregnant Marshallese women will be enrolled in the group prenatal intervention, Centering Pregnancy, with care navigation to determine the feasibility of the intervention and the preliminary effectiveness to improve maternal and infant health care outcomes.

Group II: Pregnant Marshallese women enrolled in standard prenatal care Active Control 1 Intervention

We will use a 1:1 propensity score matching with pregnant Marshallese women who completed standard prenatal care to compare their maternal and infant health care outcomes with those participants enrolled in the intervention.

Centering Pregnancy with Care Navigation is already approved in United States for the following indications:

Approved in United States as Centering Pregnancy with Care Navigation for:

• Prenatal care for high-risk pregnancies
• Improvement of prenatal and postpartum care appointment attendance
• Reduction of preterm birth and low-birth weight infants

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

Group prenatal care, which combines clinical care with peer support, has shown potential to improve health outcomes and reduce preterm birth rates, but its implementation faces various barriers at multiple levels, including patient scheduling and funding issues.

Successful adoption of group prenatal care requires strategic approaches to address these barriers, such as engaging provider champions and adapting enrollment processes, which can help sustain the model in diverse healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key Considerations for Implementing Group Prenatal Care: Lessons from 60 Practices. Pekkala, J., Cross-Barnet, C., Kirkegaard, M., et al.[2021]

CenteringPregnancy is a group prenatal care model that has been successfully implemented at over 100 sites since 1995, focusing on building relationships among women, families, and healthcare professionals.

This innovative approach provides comprehensive prenatal care in a supportive group setting, which enhances the overall health and well-being of women and their families, making it an effective and sustainable model of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CenteringPregnancy group prenatal care: Promoting relationship-centered care. Massey, Z., Rising, SS., Ickovics, J.[2022]

Group-based prenatal care is associated with improved patient outcomes, including a reduction in preterm deliveries, higher patient participation and satisfaction, and increased initiation of breastfeeding, based on a review of 11 studies.

Despite these positive associations, the research is limited by a lack of rigorous studies and a theoretical framework, indicating a need for more randomized controlled trials to better understand the effectiveness and sustainability of group prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of prenatal group care literature: the need for a structured theoretical framework and systematic evaluation. Sheeder, J., Weber Yorga, K., Kabir-Greher, K.[2021]

Group prenatal care, particularly the CenteringPregnancy model, has been linked to improved perinatal outcomes such as reduced preterm births and higher birth weights.

This model also enhances breastfeeding initiation and duration, decreases cesarean delivery rates, and increases patient satisfaction compared to traditional prenatal care methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group prenatal care: review of outcomes and recommendations for model implementation. Tilden, EL., Hersh, SR., Emeis, CL., et al.[2014]

Despite increased access to prenatal care in the U.S., there has been no significant improvement in key obstetric outcomes like preterm delivery, raising questions about the effectiveness of traditional prenatal care.

The CenteringPregnancy program, which offers group prenatal visits, has been suggested to enhance satisfaction and outcomes, but current studies lack the size and statistical power needed to confirm these benefits definitively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the CenteringPregnancy group prenatal care program reduce preterm birth? The conclusions are premature. Devitt, NF.[2018]

The CenteringPregnancy program successfully provided prenatal care to 606 low-income women in Georgia, with a significant percentage (69%) starting care in the first trimester, which is crucial for better health outcomes.

The program achieved favorable perinatal outcomes, with preterm birth and low birth weight rates at 9.1% and 8.9%, respectively, and nearly 77% of women initiating breastfeeding, indicating improved maternal and infant health in a previously underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Group Prenatal Care in Southwest Georgia Through Public-Private Partnerships. Grant, JH., Handwerk, K., Baker, K., et al.[2022]

Group prenatal care significantly reduces the risk of preterm birth and low birth weight compared to individual prenatal care, based on a study of 6,439 women over an 8.5-year period.

Women who attended five or more group prenatal care visits experienced even greater reductions in risks, with a 68% lower risk of preterm birth and a 66% lower risk of low birth weight, highlighting the importance of adherence to the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Prenatal Care Reduces Risk of Preterm Birth and Low Birth Weight: A Matched Cohort Study. Cunningham, SD., Lewis, JB., Shebl, FM., et al.[2020]

The Mama Care model of group prenatal care, adapted for women with pregnancies affected by fetal anomalies, has been successfully implemented at the Center for Fetal Diagnosis and Treatment, addressing unique challenges such as complex social needs and increased antenatal surveillance.

Outcomes from the Mama Care program indicate that group prenatal care can effectively support the specific needs of families facing prenatal diagnoses, suggesting its potential for broader application in similar high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Model of Group Prenatal Care for Patients with Prenatally Diagnosed Fetal Anomalies. Schwarz, JG., Froh, E., Farmer, MC., et al.[2021]

After the implementation of Oregon's Coordinated Care Organizations (CCOs), women on Medicaid saw a 13% increase in the likelihood of receiving first trimester prenatal care, indicating improved access to essential healthcare services.

The increase in early prenatal care was particularly notable among non-Hispanic White and Asian women, as well as women living in urban areas, suggesting that the CCO model may have varying impacts based on demographic and geographic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oregon's Coordinated Care Organizations and Their Effect on Prenatal Care Utilization Among Medicaid Enrollees. Oakley, LP., Harvey, SM., Yoon, J., et al.[2019]

In a study of 519 women receiving CenteringPregnancy group prenatal care, higher fidelity to facilitative processes was linked to significantly lower rates of preterm birth and reduced intensive care utilization, suggesting that how well the group sessions are conducted can impact pregnancy outcomes.

Content fidelity, or adherence to the recommended discussion topics, was also associated with lower intensive care utilization, highlighting the importance of both process and content in delivering effective group prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group prenatal care: model fidelity and outcomes. Novick, G., Reid, AE., Lewis, J., et al.[2022]

In a study of 15,330 pregnant women across 13 healthcare practices in South Carolina, group prenatal care significantly reduced the rates of preterm births by 3.2%, low birth weight by 3.7%, and NICU admissions by 4.0% compared to usual individual prenatal care.

The findings suggest that CenteringPregnancy group prenatal care is an effective and feasible model for improving maternal and infant health outcomes, making it a valuable option for other Perinatal Quality Collaboratives to implement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Multi-site Expansion of Group Prenatal Care on Birth Outcomes. Crockett, AH., Heberlein, EC., Smith, JC., et al.[2020]

Women with medically high-risk pregnancies who participated in group prenatal care had a significantly lower risk of neonatal intensive care unit (NICU) admissions compared to those receiving individual care (10.2% vs. 13.8%).

Those attending at least five group sessions experienced a reduced risk of preterm birth (11.4% vs. 18.4%) and NICU admissions (8.4% vs. 15.9%), suggesting that group prenatal care can be beneficial even for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Birth Outcomes for Medically High-Risk Pregnancies: Comparing Group to Individual Prenatal Care. Heberlein, EC., Smith, JC., LaBoy, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12072165/

The Effects of CenteringPregnancy: A Quasi-Experimental ... CP improved women's access to prenatal care and reduced rates of preterm birth and perinatal death compared to traditional prenatal care.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2276878/

Group Prenatal Care and Perinatal Outcomes To determine whether group prenatal care improves pregnancy outcomes, psychosocial function, and patient satisfaction and to examine potential cost differences.

3. centeringhealthcare.org centeringhealthcare.org/uploads/files/CHIAnnotatedBibliography_030525.pdf

CenteringPregnancy and CenteringParenting Summary: This is a quantitative study that compares outcomes in group prenatal care and traditional prenatal care. It concludes that women and birthing ...

4. liebertpub.com liebertpub.com/doi/10.1089/jwh.2018.7469

The Impact of CenteringPregnancy Group Prenatal Care ... The CenteringPregnancy model of group prenatal care (GPNC) has been found to be effective at reducing adverse birth outcomes, including PTB, in ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/jwh.2018.7469

The Impact of CenteringPregnancy Group Prenatal Care ... The CenteringPregnancy model of group prenatal care (GPNC) has been found to be effective at reducing adverse birth outcomes, including PTB, in ...

6. centeringhealthcare.org centeringhealthcare.org/what-we-do/centering-pregnancy

CenteringPregnancy CenteringPregnancy is group prenatal care bringing women due at the same time out of exam rooms and into a comfortable group setting.

7. ajmc.com ajmc.com/view/maternal-navigation-for-the-common-good

Maternal Navigation: For the Common Good Maternal navigation for pregnant patients who chronically miss prenatal care appointments is necessary to reduce premature births and associated ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5695671/

Does CenteringPregnancy group prenatal care affect the ... Approximately 10–15% of women report a negative birth experience, and these experiences have long-term consequences for both mother and baby. Negative birth ...

9. centeringhealthcare.org centeringhealthcare.org/uploads/files/FX_Fact-Sheet-Full-Set_NoCC.pdf

A Snapshot Centering Healthcare Institute CenteringPregnancy® is credited with an estimated cost savings of $1.5 million through a reduction in the preterm birth rate from 14% to 6% (37 preterm births) ...