Exploring the Feasibility of Centering Pregnancy With Care Navigation

Sponsor
University of Arkansas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05645549
Collaborator
(none)
40
1
2
17.9
2.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Centering Pregnancy with Care Navigation
N/A

Detailed 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. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive 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
Anticipated Study Start Date :
Mar 5, 2023
Anticipated Primary Completion Date :
Aug 30, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Centering Pregnancy with Care Navigation for pregnant Marshallese women

Forty pregnant Marshallese women will be enrolled in the group prenatal intervention, Centering Pregnancy, with care navigation to determine the feasibility of the intervention and the preliminary effectiveness to improve maternal and infant health care outcomes.

Behavioral: Centering Pregnancy with Care Navigation
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.

No Intervention: Pregnant Marshallese women enrolled in standard prenatal care

We will use a 1:1 propensity score matching with pregnant Marshallese women who completed standard prenatal care to compare their maternal and infant health care outcomes with those participants enrolled in the intervention.

Outcome Measures

Primary Outcome Measures

  1. Number of participants with infants that are preterm. [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 [All maternal and infant health records will be collected at six weeks postpartum]

    <2,500 grams

  3. Number of participants with a caesarean delivery. [All maternal and infant health records will be collected at six weeks postpartum]

    the birthing method of infant

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas for Medical Sciences-Northwest Fayetteville Arkansas United States 72701

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Britni L Ayers, PhD, University of Arkansas for Medical Sciences Northwest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT05645549
Other Study ID Numbers:
  • 275134
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2022