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Completed

NCT Number: NCT05645549

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences-Northwest

Fayetteville, Arkansas, 72701, United States

About this study

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. The Specific Aims are:

Aim 1: Determine the feasibility of Centering Pregnancy with care navigation to improve prenatal and postpartum care attendance among Marshallese participants. Hypothesis: Marshallese participants who participate in Centering Pregnancy with care navigation will attend 80% of their prenatal and postpartum care visits.

Aim 2: Determine the preliminary effectiveness of Centering Pregnancy with care navigation to improve maternal health outcomes that can mitigate maternal and infant morbidity and mortality. Hypothesis: Marshallese participants who participate in Centering Pregnancy with care navigation will demonstrate improved maternal health outcomes including: preterm birth, low-birth weight infants, cesarean deliveries, and emergency department visits compared to women receiving standard prenatal care using a propensity score matched comparison group.

Aim 3: Determine the preliminary effectiveness of Centering Pregnancy with care navigation to improve access to social support services to Marshallese participants. Hypothesis: Marshallese particiapnts who have completed Centering Pregnancy with care navigation will report improved access to social support services measured by enrollment in health insurance, maintain insurance post-partum, and access to food, transportation, and housing resources.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with infants that are preterm.

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

    >37 weeks at delivery

  2. Number of participants with infants with low birthweight

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

    <2,500 grams

  3. Number of participants with a caesarean delivery.

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

    the birthing method of infant

Secondary outcomes

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

    Time frame: All social service assessments will take place at six weeks postpartum

    We will assess the enrollment of social services with a bilingual Marshallese care navigator using a mixed methods approach

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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