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Group-Based Prenatal Care for Preventing Premature Birth

N/A

Recruiting

Led By Britni L Ayers, PhD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all maternal and infant health records will be collected at six weeks postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial will measure if group-based prenatal care with care navigation can improve health outcomes for US Pacific Islanders, reducing infant & maternal mortality & morbidity.

Who is the study for?

This trial is for pregnant Marshallese women, aged 18 or older, who are in their first trimester (12-14 weeks gestation). It's not open to those who used fertility treatments, have a high-risk pregnancy requiring special care, are expecting multiple babies, or take medications that affect fetal growth.

What is being tested?

The study tests 'Centering Pregnancy with Care Navigation' against standard prenatal care. It aims to see if this group-based program can improve attendance at care appointments and outcomes like preterm birth rates and infant weight.

What are the potential side effects?

Since the intervention involves supportive group prenatal programs rather than medication, there aren't typical side effects. However, participants may experience varying levels of emotional comfort or stress due to the social nature of the program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all maternal and infant health records will be collected at six weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all maternal and infant health records will be collected at six weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and all maternal and infant health records will be collected at six weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with a caesarean delivery.

Number of participants with infants that are preterm.

Number of participants with infants with low birthweight

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Centering Pregnancy with Care Navigation for pregnant Marshallese womenExperimental Treatment1 Intervention

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.

Group II: Pregnant Marshallese women enrolled in standard prenatal careActive Control1 Intervention

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.

Do I qualify?Apply below to find out