Premature Birth Clinical Trial
Official title:
Exploring the Feasibility of Centering Pregnancy With Care Navigation and the Preliminary Effectiveness to Improve Prenatal and Postpartum Appointment Attendance, Maternal and Infant Outcomes, and Access to Social Support Services
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 1, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences-Northwest | Fayetteville | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Number of participants with infants with low birthweight | <2,500 grams | All maternal and infant health records will be collected at six weeks postpartum | |
Primary | 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 | The number of social services participants are enrolled in at the end of the intervention. | We will assess the enrollment of social services with a bilingual Marshallese care navigator using a mixed methods approach | All social service assessments will take place at six weeks postpartum |
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