Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"

Completed · Not applicable

Conditions studied: Pregnancy, Premature Birth, Infant, Low Birth Weight, Postpartum Period, Sexually Transmitted Diseases

In brief

This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could be scaled nationally. Group prenatal care models have been demonstrated through rigorous research to provide significantly improved birth outcomes with implications for maternal-child health and substantial cost savings. However, group prenatal care is currently available to only a small fraction of the more than four million women who give birth annually in the US. Through the development, implementation and evaluation of a new model of group prenatal care, we will create an outcomes-focused model of group prenatal care that will be scalable nationally with an eye toward improving US birth outcomes. The long-term objective of the proposed study is to reduce the risk for adverse perinatal outcomes during and after pregnancy among women and families receiving prenatal care in health centers in 3 geographic locations serving vulnerable populations: Hidalgo County Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate a new and improved model of group prenatal care, "Expect with Me," based on our previous research on group models of prenatal care, which has already yielded favorable behavioral and biological results in two randomized controlled trials. We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive "Expect with Me" group prenatal care will be significantly more likely to: 1. have better perinatal outcomes, including better health behaviors during pregnancy (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum indicators (e.g., increased breastfeeding); 2. report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness; 3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum; 4. have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays) Comparisons based on propensity-score matched sample of women receiving standard individual prenatal care at the same clinical sites.

Key facts

Study ID

NCT02169024

Run by

Yale University

People needed

2402

Starts

2014-02-01

Expected to finish

2017-12-01

Last updated by the study team

2020-05-29

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• less than 24 weeks pregnant
• able to attend groups conducted in English or Spanish
• consent to share their data with the study

You may not qualify if…

• severe medical problem requiring individual care only, as determined by the participating clinical practice

Where it is running

• Wayne State University — Detroit, Michigan, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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