Exploring the Feasibility of Centering Pregnancy With Care Navigation

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645549
• Other study ID #: 275134
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: University of Arkansas
• Contact: Britni L Ayers, PhD
• Phone: 479-644-1096
• Email: blayers[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences-Northwest	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

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