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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02169024
Enrollment
2402
Registered
2014-06-20
Start date
2014-02-28
Completion date
2017-12-31
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

prenatal care, group care, Expect With Me, evaluation studies, group prenatal care

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)

Interventions

BEHAVIORALExpect With Me group prenatal care

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.

OTHERStandard individual prenatal care

Standard of care- individual prenatal care

Sponsors

United Health Foundation
CollaboratorUNKNOWN
Yale University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Expect With Me group prenatal care vs. Individual Care Only prenatal care

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Risk of preterm birth incidenceup to 37 weeks gestationIncidence risk of delivery before 37 weeks gestation
Risk of neonatal intensive care unit (NICU) admission incidencebirthIncidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
Risk of small for gestational age incidencedeliveryIncidence risk of infant weight below the 10th percentile for the gestational age at birth
Risk of low birth weight incidencedeliveryIncidence risk of infant weight at birth \< 2500 grams

Secondary

MeasureTime frameDescription
social support2nd and 3rd trimester and 6 and 12 months postpartummultidimensional scale of perceived social support subscale
substance use2nd and 3rd trimester and 6 and 12 months postpartumuse of cigarettes, alcohol, and drugs
care satisfaction3rd trimestersatisfaction with Expect With Me group prenatal care and use of program components
adherence to medical recommendations6 & 12 months postpartumadherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
postpartum body mass indexmeasured at 6 and 12 months postpartumindividual's body weight divided by the square of their height (kg/m2)
maternal weight gainmeasured at 2nd and 3rd trimester and birthweight gain as compared to medical recommendations
mode of deliverydeliverymode of delivery (e.g., cesarean, vaginal)
sexual risk: condom usemeasured at 2nd and 3rd trimester and 6 and 12 months postpartumcondom use percent (0-100%)
sexual risk: contraceptive use (LARC)measured at 2nd and 3rd trimester and 6 and 12 months postpartumuse of other contraceptives to prevent pregnancy (no/yes)
sexual risk: number of sexual partnersmeasured at 2nd and 3rd trimester and 6 and 12 months postpartumnumber of partners
sexual risk: sexually transmitted infectionmeasured at 2nd and 3rd trimester and 6 and 12 months postpartumsexually transmitted infection (no/yes, during pregnancy or incident postpartum)
breastfeeding6 and 12 months postpartuminitiation and duration of breastfeeding
nutrition2nd and 3rd trimester of pregnancy and 6 and 12 months postpartumnutritional choices, food security, and use of mindful eating practices
physical activity2nd and 3rd trimester and 6 and 12 months postpartumlevel of physical activity in a typical week
readiness for labor and deliverymeasured at 2nd and third trimesterreadiness for labor and delivery
readiness for taking care of baby2nd and 3rd trimester of pregnancyreadiness for taking care of baby
condom use self-efficacy2nd and 3rd trimester and 6 and 12 months postpartumcondom use self efficacy scale

Other

MeasureTime frameDescription
intimate partner violencemeasured at 2nd and 3rd trimester and 6 and 12 months postpartumperpetration and victimization of violence by an intimate partner
perceived stress2nd and 3rd trimester and 6 and 12 months postpartumstress level as reported by patient
depressive symptomatology2nd and 3rd trimester of pregnancypatient endorsement of depressive symptoms
perceived discrimination2nd and 3rd trimester of pregnancy and 6 and 12 months postpartumpatient experiences of discrimination
resilience2nd and 3rd trimester of pregnancy and 6 and 12 months postpartumshift and persist scale
nurse visitation2nd and 3rd trimester of pregnancyparticipation in a nurse visitation program
transfer of motivation2nd and3rd trimester and 6 and 12 months postpartumrelation of motivation for self and baby's health
living situation2nd and 3rd trimester and 6 and 12 months postpartumwhere and with whom they live with and the stability of their housing
sexual debut2nd trimester pregnancyage at first intercourse
confidence in parenting skills6 and 12 months postpartumconfidence in parenting skills

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026