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Exploring the Feasibility of Centering Pregnancy With Care Navigation
NCT05645549 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BEHAVIORAL Centering Pregnancy with Care Navigation
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences-Northwest — Fayetteville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2026-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05645549
The ClinicalTrials.gov registry entry for NCT05645549 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 194 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Premature Birth appearing as the primary indexed condition, and to 1 intervention — of which Centering Pregnancy with Care Navigation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05645549 reports 1 study location spanning 1 distinct geographic area — top geographies include Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05645549 about?
NCT05645549 is a clinical study titled "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 ...
What is the current status of trial NCT05645549?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 38 participants. The study started on 2023-04-17. Estimated completion is 2026-03-01.
What conditions does trial NCT05645549 study?
This clinical trial studies the following conditions: Premature Birth. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05645549?
The interventions under investigation include: Centering Pregnancy with Care Navigation (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05645549?
This trial is sponsored by University of Arkansas, which has 194 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05645549 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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