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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Centering Pregnancy with Care Navigation for preventing premature birth?

Research shows that group prenatal care, like Centering Pregnancy, can lower the chances of preterm births and low birth weight. In a study with over 15,000 women, those who attended group prenatal care had fewer preterm births and babies with low birth weight compared to those who had individual care. ^{1 2 3 4 5}

Is group-based prenatal care safe for preventing premature birth?

Group-based prenatal care, such as CenteringPregnancy, has been shown to be safe and can reduce the risk of preterm birth and low birth weight. It has been successfully implemented in various settings, improving outcomes for both mothers and infants. ^{2 3 5 6 7}

How is the treatment 'Group-Based Prenatal Care with Care Navigation' different from other treatments for preventing premature birth?

This treatment is unique because it combines clinical care with peer support and education in a group setting, which can improve satisfaction and potentially enhance pregnancy outcomes compared to traditional individual prenatal visits. ^{8 9 10 11 12}

What is the purpose of this trial?

Pacific Islanders residing in the United States (US) have disproportionally high rates of preterm birth (\<37 weeks) and low birthweight infants (\<2,500 grams). They are also more likely to experience preeclampsia, primary cesarean birth, excessive gestational weight gain, and gestational diabetes mellitus (GDM) compared to other racial/ethnic minorities. These maternal health factors serve as precursors to maternal and infant morbidity and mortality. Pacific Islanders have almost twice the infant mortality rate, per 1,000 live births, as compared to non-Hispanic whites and have a higher maternal mortality rate compared to the same group (13.5 verse 12.7). Early and consistent supportive care throughout the pregnancy continuum is strongly associated with positive birth outcomes, including infant and maternal morbidity and mortality, and is a US health priority. Emerging literature suggests that group-based prenatal programs, like Centering Pregnancy, coupled with care navigation, can mitigate precursors to severe morbidity and mortality. The proposed study will determine the feasibility of Centering Pregnancy with care navigation and the preliminary effectiveness to improve: prenatal and postpartum care appointment attendance, preterm birth, low-birth weight infants, cesarean deliveries, emergency department visits, and access to social support services. Investigators will use a mixed-method approach with two groups of Marshallese participants (propensity score matched on relevant covariates such as maternal age, parity, and sociodemographics), one group in Centering Pregnancy with care navigation and one group from standard prenatal care.

Research Team

Britni L Ayers, PhD

Principal Investigator

University of Arkansas for Medical Sciences Northwest

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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, 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]

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]

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 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]

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]

References

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

Oregon's Coordinated Care Organizations and Their Effect on Prenatal Care Utilization Among Medicaid Enrollees. [2019]

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

Group Prenatal Care Reduces Risk of Preterm Birth and Low Birth Weight: A Matched Cohort Study. [2020]

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

Group prenatal care: model fidelity and outcomes. [2022]

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

A review of prenatal group care literature: the need for a structured theoretical framework and systematic evaluation. [2021]

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

Effects of a Multi-site Expansion of Group Prenatal Care on Birth Outcomes. [2020]

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

Birth Outcomes for Medically High-Risk Pregnancies: Comparing Group to Individual Prenatal Care. [2022]

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

Implementing Group Prenatal Care in Southwest Georgia Through Public-Private Partnerships. [2022]

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

Group prenatal care: review of outcomes and recommendations for model implementation. [2014]

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

Key Considerations for Implementing Group Prenatal Care: Lessons from 60 Practices. [2021]

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

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

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

A Model of Group Prenatal Care for Patients with Prenatally Diagnosed Fetal Anomalies. [2021]

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

CenteringPregnancy group prenatal care: Promoting relationship-centered care. [2022]