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Exploring the Feasibility of Centering Pregnancy With Care Navigation

Primary Purpose

Premature Birth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Centering Pregnancy with Care Navigation
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences-NorthwestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Centering Pregnancy with Care Navigation for pregnant Marshallese women

Pregnant Marshallese women enrolled in standard prenatal care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants with infants that are preterm.
>37 weeks at delivery
Number of participants with infants with low birthweight
<2,500 grams
Number of participants with a caesarean delivery.
the birthing method of infant

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2022
Last Updated
May 8, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT05645549
Brief Title
Exploring the Feasibility of Centering Pregnancy With Care Navigation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Centering Pregnancy with Care Navigation for pregnant Marshallese women
Arm Type
Experimental
Arm Description
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.
Arm Title
Pregnant Marshallese women enrolled in standard prenatal care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Centering Pregnancy with Care Navigation
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with infants that are preterm.
Description
>37 weeks at delivery
Time Frame
All maternal and infant health records will be collected at six weeks postpartum
Title
Number of participants with infants with low birthweight
Description
<2,500 grams
Time Frame
All maternal and infant health records will be collected at six weeks postpartum
Title
Number of participants with a caesarean delivery.
Description
the birthing method of infant
Time Frame
All maternal and infant health records will be collected at six weeks postpartum
Secondary Outcome Measure Information:
Title
The number of social services participants are enrolled in at the end of the intervention.
Description
We will assess the enrollment of social services with a bilingual Marshallese care navigator using a mixed methods approach
Time Frame
All social service assessments will take place at six weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Britni L Ayers, PhD
Phone
479-644-1096
Email
blayers@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pearl A McElfish, PhD
Phone
479-713-8680
Email
pamcelfish@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britni L Ayers, PhD
Organizational Affiliation
University of Arkansas for Medical Sciences Northwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences-Northwest
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britni L ayers, PhD
Phone
479-644-1096
Email
blayers@uams.edu
First Name & Middle Initial & Last Name & Degree
Pearl A McElfish, PhD
Phone
479-713-8680
Email
pamcelfish@uams.edu

12. IPD Sharing Statement

Learn more about this trial

Exploring the Feasibility of Centering Pregnancy With Care Navigation

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