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NCT02169024 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Yale University.

Completed
Registry status
NA
Development phase
2,402
Enrollment target

NCT02169024: Completed NA study, sponsored by Yale University.

NCT02169024 is a NA study that has completed, run by Yale University. The registered enrollment target is 2,402 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02169024, a NA study, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
2,402 participants
Enrollment target

Study Summary

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 characteristic

Primary Outcome

Incidence risk of delivery before 37 weeks gestation

Interventions

  • BEHAVIORAL Expect With Me group prenatal care
  • OTHER Standard individual prenatal care

Trial Details

FieldValue
Enrollment Target 2,402 participants
Start Date 2014-02
Est. Completion 2017-12
Phase NA
Yale University

1,492 total trials

What the finished NCT02169024 record still lists

NCT02169024 is an interventional study that assigns participants to a tested intervention. Its 2,402 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% higher).

The record links to 0 conditions, and to 2 interventions - of which Expect With Me group prenatal care is the first listed.

NCT02169024 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02169024 about?

NCT02169024 is a clinical study titled "Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"". 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 ...

What is the current status of trial NCT02169024?

This trial is currently completed. It is a NA study. The enrollment target is 2,402 participants. The study started on 2014-02. Estimated completion is 2017-12.

What interventions are being tested in trial NCT02169024?

The interventions under investigation include: Expect With Me group prenatal care (BEHAVIORAL), Standard individual prenatal care (OTHER).

Who is sponsoring clinical trial NCT02169024?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02169024's enrollment target sits among peer trials

2,402 46th of 2000 higher than 1,955 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02169024, the US trial registry maintained by the National Library of Medicine. NCT02169024 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.