ACTIVE_NOT_RECRUITING

Exploring the Feasibility of Centering Pregnancy With Care Navigation

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-04-17
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05645549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * women who self-report as Marshallese
  2. * 18 years of age or older
  3. * pregnant (12-14 weeks gestation).
  1. * conception with the use of fertility treatments
  2. * high-risk pregnancy that requires a transfer to a high-risk clinic
  3. * multiple gestations (i.e. pregnant with more than one infant)
  4. * use of medications known to influence fetal growth (e.g., glucocorticoids, insulin, thyroid, hormones

Contacts and Locations

Principal Investigator

Britni L Ayers, PhD
PRINCIPAL_INVESTIGATOR
University of Arkansas for Medical Sciences Northwest

Study Locations (Sites)

University of Arkansas for Medical Sciences-Northwest
Fayetteville, Arkansas, 72701
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Britni L Ayers, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas for Medical Sciences Northwest

Study Record Dates

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

Study Start Date2023-04-17
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Premature Birth