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Completed

NCT Number: NCT02169024

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 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.

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Key information

About this study

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.

Specific Aims:

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. The overall objective of this project is to improve maternal health and reduce adverse birth outcomes. We will meet this objective by achieving three specific goals:

  • Develop a new and improved model of group prenatal care, including curriculum, training materials, IT infrastructure and marketing materials to support broad adoption of group prenatal care, enhance consumer experience, monitor patient outcomes, and ensure national scalability.
  • Implement group prenatal care in three communities at high risk for adverse perinatal outcomes (Hidalgo County TX, Nashville TN, Detroit MI), engaging and training providers in group facilitation and the established curriculum, engaging patients through improved in-reach and outreach strategies, and implementing IT infrastructure to improve uptake, patient experience, and sustainability through the monitoring of patient outcomes.
  • Evaluate the effect of implementing group prenatal care through a rigorous process and outcome evaluation that identifies any barriers to national scalability and examines maternal health and birth outcomes and resultant cost implications.

Specific Study Hypotheses

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:

  • 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);
  • report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
  • have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
  • have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Expect With Me group prenatal care

Behavioral

Expect With Me group prenatal care was designed based on: principles of group care; evidence from RCTs demonstrating improved birth outcomes; ACOG clinical guidelines; and research on patient and provider engagement through technology. Designed with national dissemination as a primary consideration, Expect With Me incorporates best evidence-based aspects of existing models of group care, with a novel IT platform to improve patient engagement and support, enhance health behaviors and decision making, connect providers and patients, and improve health service delivery. Expect With Me provides care to groups of 8-12 women of the same gestational age, implemented after initial individual assessment through delivery. Group visits are 90-120 minutes each, and follow a structured curriculum that incorporates standard content of prenatal care, and emphasizes critical health issues relevant to pregnancy, such as nutrition, physical activity, stress/mental health and sexual health.

Other names: group prenatal care

Standard individual prenatal care

Other

Standard of care- individual prenatal care

Other names: Individual Care Only

Primary outcomes

  1. Risk of preterm birth incidence

    Time frame: up to 37 weeks gestation

    Incidence risk of delivery before 37 weeks gestation

  2. Risk of low birth weight incidence

    Time frame: delivery

    Incidence risk of infant weight at birth < 2500 grams

  3. Risk of small for gestational age incidence

    Time frame: delivery

    Incidence risk of infant weight below the 10th percentile for the gestational age at birth

  4. Risk of neonatal intensive care unit (NICU) admission incidence

    Time frame: birth

    Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth

Secondary outcomes

  1. breastfeeding

    Time frame: 6 and 12 months postpartum

    initiation and duration of breastfeeding

  2. nutrition

    Time frame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum

    nutritional choices, food security, and use of mindful eating practices

  3. physical activity

    Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum

    level of physical activity in a typical week

  4. readiness for labor and delivery

    Time frame: measured at 2nd and third trimester

    readiness for labor and delivery

  5. readiness for taking care of baby

    Time frame: 2nd and 3rd trimester of pregnancy

    readiness for taking care of baby

  6. social support

    Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum

    multidimensional scale of perceived social support subscale

  7. condom use self-efficacy

    Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum

    condom use self efficacy scale

  8. substance use

    Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum

    use of cigarettes, alcohol, and drugs

  9. care satisfaction

    Time frame: 3rd trimester

    satisfaction with Expect With Me group prenatal care and use of program components

  10. adherence to medical recommendations

    Time frame: 6 & 12 months postpartum

    adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)

  11. postpartum body mass index

    Time frame: measured at 6 and 12 months postpartum

    individual's body weight divided by the square of their height (kg/m2)

  12. maternal weight gain

    Time frame: measured at 2nd and 3rd trimester and birth

    weight gain as compared to medical recommendations

  13. mode of delivery

    Time frame: delivery

    mode of delivery (e.g., cesarean, vaginal)

  14. sexual risk: condom use

    Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum

    condom use percent (0-100%)

  15. sexual risk: contraceptive use (LARC)

    Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum

    use of other contraceptives to prevent pregnancy (no/yes)

  16. sexual risk: number of sexual partners

    Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum

    number of partners

  17. sexual risk: sexually transmitted infection

    Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum

    sexually transmitted infection (no/yes, during pregnancy or incident postpartum)

Other outcomes

  1. nurse visitation

    Time frame: 2nd and 3rd trimester of pregnancy

    participation in a nurse visitation program

  2. sexual debut

    Time frame: 2nd trimester pregnancy

    age at first intercourse

  3. living situation

    Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum

    where and with whom they live with and the stability of their housing

  4. transfer of motivation

    Time frame: 2nd and3rd trimester and 6 and 12 months postpartum

    relation of motivation for self and baby's health

  5. confidence in parenting skills

    Time frame: 6 and 12 months postpartum

    confidence in parenting skills

  6. intimate partner violence

    Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum

    perpetration and victimization of violence by an intimate partner

  7. perceived stress

    Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum

    stress level as reported by patient

  8. depressive symptomatology

    Time frame: 2nd and 3rd trimester of pregnancy

    patient endorsement of depressive symptoms

  9. perceived discrimination

    Time frame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum

    patient experiences of discrimination

  10. resilience

    Time frame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum

    shift and persist scale

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • United Health Foundation

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 20, 2014
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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