Mobile CenteringPregnancy for Prenatal Care

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, Multiple gestations

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

Compensation: Varies

Number of Visits: 14

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of providing prenatal care for Marshallese women using a group model called Mobile CenteringPregnancy. The goal is to determine if this approach can improve birth outcomes, such as reducing preterm births and low birth weight, by offering prenatal care directly in the community. Pregnant women (12-14 weeks along) who identify as Marshallese may be suitable for this trial. The study aims to find effective methods to support better health for both mothers and babies, ultimately reducing the risk of childhood obesity. As an unphased trial, participants contribute to pioneering research that may enhance prenatal care for their community.

Will I have to stop taking my current medications?

If you are taking medications that can affect fetal growth, like glucocorticoids, insulin, or thyroid hormones, you may not be eligible for this trial. It's best to discuss your current medications with the trial team to see if you can participate.

What prior data suggests that the Mobile CenteringPregnancy program is safe for prenatal care?

Research has shown that group prenatal care, such as the Mobile CenteringPregnancy model, is generally well-received. Women participating in this type of care often experience fewer early births and have healthier babies. One study found that women in group prenatal care were less likely to have premature births. Another study demonstrated that these group sessions improve mothers' health and foster trust and confidence among families.

Overall, strong evidence indicates that group prenatal care is safe and beneficial for both mothers and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mobile CenteringPregnancy because it offers a fresh take on prenatal care through group sessions rather than traditional one-on-one visits. This method brings together pregnant women with similar due dates to share their experiences, providing emotional support and fostering a sense of community. Studies have shown that this group approach can lead to healthier outcomes, such as reduced rates of preterm births and low birth weight, as well as improved maternal mental health and satisfaction. By incorporating mobile health clinics, this approach also makes accessing care more convenient, especially for those in underserved areas.

What evidence suggests that Mobile CenteringPregnancy is effective for improving prenatal care outcomes for Pacific Islanders?

Research has shown that CenteringPregnancy, a group prenatal care model, effectively lowers the chances of early births and underweight babies. In a large study, this care reduced the risk of early birth by 33%. It also improves mothers' mental health, increases breastfeeding rates, and supports healthy weight gain during pregnancy. These benefits lead to better health for both mothers and babies. In this trial, participants will receive group prenatal care through mobile health clinics, aiming to bring these positive effects directly to communities in need, such as the Marshallese community. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Marshallese women in Arkansas who are at least 18 years old and pregnant (12-14 weeks gestation confirmed with ultrasound). It aims to improve maternal and infant health outcomes, particularly addressing high rates of preterm birth and low birthweight among this community.

Inclusion Criteria

Women who self-report as Marshallese

I am 18 years old or older.

Pregnant (12-14 weeks gestation; confirmed with ultrasound)

Exclusion Criteria

Conception with the use of fertility treatments

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

I am taking medication that could affect fetal growth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Care

Participants attend routine one-on-one prenatal appointments prior to the intervention

14 weeks

Regular visits until week 14 of pregnancy

Group Prenatal Care

Participants engage in group prenatal care sessions from week 14 of pregnancy through birth

Approximately 26 weeks

Group sessions at mobile health clinics

Follow-up

Participants are monitored for preterm birth and maternal health outcomes

3 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Mobile CenteringPregnancy

Trial Overview The study tests the effectiveness of Mobile CenteringPregnancy, a group prenatal care model delivered via mobile health clinics. This approach challenges standard one-on-one counseling by providing direct services to communities facing transportation barriers.

How Is the Trial Designed?

Group I: Group prenatal care Experimental Treatment 1 Intervention

. CenteringPregnancy, a group prenatal care model, is a promising alternative that challenges the standard model of one-on-one prenatal counseling. Previous research has documented that group prenatal care is associated with a lower prevalence of preterm birth and low birth weight infants. 18,39 Group prenatal care also has been associated with improved maternal mental health, breastfeeding, optimal pregnancy weight gain, improved postpartum weight loss, better birth spacing, and higher patient satisfaction. 18,39 All participants will attend routine one-on-one prenatal appointments prior to the intervention. The sessions occur from week 14 of pregnancy through birth with women of similar gestational age, following the same schedule as standard care. Once the groups of women are formed (5 per group), the participants attend all appointments together for the duration of their pregnancies. Mobile health clinic located at FBOs will provide a location for providers to provide brief one-on

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818867

Group Multimodal Prenatal Care and Postpartum Outcomes This cohort study compares postpartum psychosocial outcomes and perceived quality of prenatal care associated with group prenatal care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3726551/

Group Prenatal Care: Model Fidelity and Outcomes - PMC In a large multi-site randomized controlled trial, CenteringPregnancy group prenatal care reduced the likelihood of preterm birth by 33%, with an even greater ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT05645549/Prot_SAP_000.pdf

Determine the Preliminary Effectiveness of Mobile ... The focus groups will focus on beliefs and experiences of individualized and group prenatal care, prenatal care satisfaction, and health ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1871519224000660

Women's experiences with Centering-Based Group Care in ... A quasi-experimental study linked CBGC to positive outcomes for obese, unmarried, and low-income women [25]. Nevertheless, other studies showed divergent ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10765290/

Mobile Prenatal Education and Its Impact on Reducing ... This study aims to develop and evaluate the effectiveness of a mobile-based prenatal education program in improving pregnancy outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3489125/

Exploring the Group Prenatal Care Model: A Critical ... (2007) found that women assigned to group prenatal care (CenteringPregnancy) were significantly less likely to experience a preterm birth than women in ...

7. rutgers.edu rutgers.edu/news/model-group-prenatal-care-bolsters-patient-satisfaction-support-and-trust-researchers-find

Model for Group Prenatal Care Bolsters Patient Satisfaction ... “The findings confirm that group prenatal care strengthens maternal health and builds trust, support, and confidence for families during one of ...

8. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-017-1522-2

A systematic overview of the literature regarding group ... Attendance at prenatal visits was shown to increase among women in GPC in the following groups: Opioid Addiction, Adolescents, and Low-Income.

9. mdpi.com mdpi.com/2077-0383/11/17/5015

Impact of Group vs. Individual Prenatal Care Provision on ... This study compares the level of knowledge on subjects pertaining to pregnancy and birth in low-risk pregnancies when delivered in group versus individual ...