Exploring the Feasibility of Centering Pregnancy With Care Navigation

NCT05645549 | Completed

• 1 other identifier: 275134
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (3)

• Number of participants with infants that are preterm.

  \>37 weeks at delivery

  All maternal and infant health records will be collected at six weeks postpartum

• Number of participants with infants with low birthweight

  \<2,500 grams

  All maternal and infant health records will be collected at six weeks postpartum

• Number of participants with a caesarean delivery.

  the birthing method of infant

  All maternal and infant health records will be collected at six weeks postpartum

Secondary Outcomes (1)

• The number of social services participants are enrolled in at the end of the intervention.

  All social service assessments will take place at six weeks postpartum

Study Arms (2)

Centering Pregnancy with Care Navigation for pregnant Marshallese women

EXPERIMENTAL

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.

Behavioral: Centering Pregnancy with Care Navigation

Pregnant Marshallese women enrolled in standard prenatal care

NO 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.

Interventions

Centering Pregnancy with Care Navigation BEHAVIORAL

Centering Pregnancy is a group based prenatal care intervention. Centering Pregnancy is an evidenced based intervention that has 10 group sessions for pregnant women. Each session has dedicated educational material relative to pregnancy, birth, and infant feeding. In addition, all participants will be provided a bilingual Marshallese care navigator to aid in enrolling them in social support services.

Centering Pregnancy with Care Navigation for pregnant Marshallese women

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women who self-report as Marshallese
• years of age or older
• pregnant (12-14 weeks gestation).

You may not qualify if:

• conception with the use of fertility treatments
• high-risk pregnancy that requires a transfer to a high-risk clinic
• multiple gestations (i.e. pregnant with more than one infant)
• use of medications known to influence fetal growth (e.g., glucocorticoids, insulin, thyroid, hormones

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences-Northwest

Fayetteville, Arkansas, 72701, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Britni L Ayers, PhD

  University of Arkansas for Medical Sciences Northwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: April 17, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2025-09

Locations

US (1)