Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
- Conditions
- Infant, Low Birth WeightSexually Transmitted DiseasesPostpartum PeriodPregnancyPremature Birth
- Interventions
- Other: Standard individual prenatal careBehavioral: Expect With Me group prenatal care
- Registration Number
- NCT02169024
- Lead Sponsor
- Yale University
- Brief 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 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.
- Detailed Description
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:
1. 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.
2. 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.
3. 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:
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2402
- less than 24 weeks pregnant
- able to attend groups conducted in English or Spanish
- consent to share their data with the study
- severe medical problem requiring individual care only, as determined by the participating clinical practice
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individual Care Only Standard individual prenatal care Standard of Care- individual prenatal care Expect With Me group prenatal care Expect With Me group prenatal care receiving prenatal care through an Expect With Me group
- Primary Outcome Measures
Name Time Method Risk of low birth weight incidence delivery Incidence risk of infant weight at birth \< 2500 grams
Risk of preterm birth incidence up to 37 weeks gestation Incidence risk of delivery before 37 weeks gestation
Risk of neonatal intensive care unit (NICU) admission incidence birth Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
Risk of small for gestational age incidence delivery Incidence risk of infant weight below the 10th percentile for the gestational age at birth
- Secondary Outcome Measures
Name Time Method mode of delivery delivery mode of delivery (e.g., cesarean, vaginal)
breastfeeding 6 and 12 months postpartum initiation and duration of breastfeeding
nutrition 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum nutritional choices, food security, and use of mindful eating practices
physical activity 2nd and 3rd trimester and 6 and 12 months postpartum level of physical activity in a typical week
care satisfaction 3rd trimester satisfaction with Expect With Me group prenatal care and use of program components
maternal weight gain measured at 2nd and 3rd trimester and birth weight gain as compared to medical recommendations
sexual risk: contraceptive use (LARC) measured at 2nd and 3rd trimester and 6 and 12 months postpartum use of other contraceptives to prevent pregnancy (no/yes)
adherence to medical recommendations 6 & 12 months postpartum adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
postpartum body mass index measured at 6 and 12 months postpartum individual's body weight divided by the square of their height (kg/m2)
sexual risk: condom use measured at 2nd and 3rd trimester and 6 and 12 months postpartum condom use percent (0-100%)
sexual risk: number of sexual partners measured at 2nd and 3rd trimester and 6 and 12 months postpartum number of partners
readiness for labor and delivery measured at 2nd and third trimester readiness for labor and delivery
readiness for taking care of baby 2nd and 3rd trimester of pregnancy readiness for taking care of baby
social support 2nd and 3rd trimester and 6 and 12 months postpartum multidimensional scale of perceived social support subscale
condom use self-efficacy 2nd and 3rd trimester and 6 and 12 months postpartum condom use self efficacy scale
substance use 2nd and 3rd trimester and 6 and 12 months postpartum use of cigarettes, alcohol, and drugs
sexual risk: sexually transmitted infection measured at 2nd and 3rd trimester and 6 and 12 months postpartum sexually transmitted infection (no/yes, during pregnancy or incident postpartum)
Trial Locations
- Locations (2)
Wayne State University
🇺🇸Detroit, Michigan, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States