Exploring the Feasibility of Centering Pregnancy With Care Navigation
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
🗓️ Study Start (Actual)
17 April 2023
🗓️ Primary Completion (Estimated)
30 July 2025
✅ Study Completion (Estimated)
1 August 2025
👥 Enrollment (Estimated)
40
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Fayetteville, Arkansas, United States
Description
Inclusion Criteria:
- * women who self-report as Marshallese
- * 18 years of age or older
- * pregnant (12-14 weeks gestation).
Exclusion Criteria:
- * 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
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
1 December 2022
- First Submitted that Met QC Criteria
1 December 2022
- First Posted
9 December 2022
Study Record Updates
- Last Update Submitted that Met QC Criteria
1 July 2024
- Last Update Posted
3 July 2024
- Last Verified
July 2024