- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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:
- 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)
Comparisons based on propensity-score matched sample of women receiving standard individual prenatal care at the same clinical sites.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Expect With Me group prenatal care
receiving prenatal care through an Expect With Me group
|
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:
|
Active Comparator: Individual Care Only
Standard of Care- individual prenatal care
|
Standard of care- individual prenatal care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk of preterm birth incidence
Time Frame: up to 37 weeks gestation
|
Incidence risk of delivery before 37 weeks gestation
|
up to 37 weeks gestation
|
Risk of low birth weight incidence
Time Frame: delivery
|
Incidence risk of infant weight at birth < 2500 grams
|
delivery
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Risk of small for gestational age incidence
Time Frame: delivery
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Incidence risk of infant weight below the 10th percentile for the gestational age at birth
|
delivery
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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
|
birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
breastfeeding
Time Frame: 6 and 12 months postpartum
|
initiation and duration of breastfeeding
|
6 and 12 months postpartum
|
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
|
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
|
physical activity
Time Frame: 2nd and 3rd trimester and 6 and 12 months postpartum
|
level of physical activity in a typical week
|
2nd and 3rd trimester and 6 and 12 months postpartum
|
readiness for labor and delivery
Time Frame: measured at 2nd and third trimester
|
readiness for labor and delivery
|
measured at 2nd and third trimester
|
readiness for taking care of baby
Time Frame: 2nd and 3rd trimester of pregnancy
|
readiness for taking care of baby
|
2nd and 3rd trimester of pregnancy
|
social support
Time Frame: 2nd and 3rd trimester and 6 and 12 months postpartum
|
multidimensional scale of perceived social support subscale
|
2nd and 3rd trimester and 6 and 12 months postpartum
|
condom use self-efficacy
Time Frame: 2nd and 3rd trimester and 6 and 12 months postpartum
|
condom use self efficacy scale
|
2nd and 3rd trimester and 6 and 12 months postpartum
|
substance use
Time Frame: 2nd and 3rd trimester and 6 and 12 months postpartum
|
use of cigarettes, alcohol, and drugs
|
2nd and 3rd trimester and 6 and 12 months postpartum
|
care satisfaction
Time Frame: 3rd trimester
|
satisfaction with Expect With Me group prenatal care and use of program components
|
3rd trimester
|
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)
|
6 & 12 months postpartum
|
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)
|
measured at 6 and 12 months postpartum
|
maternal weight gain
Time Frame: measured at 2nd and 3rd trimester and birth
|
weight gain as compared to medical recommendations
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measured at 2nd and 3rd trimester and birth
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mode of delivery
Time Frame: delivery
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mode of delivery (e.g., cesarean, vaginal)
|
delivery
|
sexual risk: condom use
Time Frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
condom use percent (0-100%)
|
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
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)
|
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
sexual risk: number of sexual partners
Time Frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
number of partners
|
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
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)
|
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nurse visitation
Time Frame: 2nd and 3rd trimester of pregnancy
|
participation in a nurse visitation program
|
2nd and 3rd trimester of pregnancy
|
sexual debut
Time Frame: 2nd trimester pregnancy
|
age at first intercourse
|
2nd trimester pregnancy
|
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
|
2nd and 3rd trimester and 6 and 12 months postpartum
|
transfer of motivation
Time Frame: 2nd and3rd trimester and 6 and 12 months postpartum
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relation of motivation for self and baby's health
|
2nd and3rd trimester and 6 and 12 months postpartum
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confidence in parenting skills
Time Frame: 6 and 12 months postpartum
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confidence in parenting skills
|
6 and 12 months postpartum
|
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
|
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
perceived stress
Time Frame: 2nd and 3rd trimester and 6 and 12 months postpartum
|
stress level as reported by patient
|
2nd and 3rd trimester and 6 and 12 months postpartum
|
depressive symptomatology
Time Frame: 2nd and 3rd trimester of pregnancy
|
patient endorsement of depressive symptoms
|
2nd and 3rd trimester of pregnancy
|
perceived discrimination
Time Frame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
|
patient experiences of discrimination
|
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
|
resilience
Time Frame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
|
shift and persist scale
|
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeannette R Ickovics, Ph.D., Yale School of Public Health
- Study Director: Jessica B Lewis, PhD, MFT, Yale School of Public Health
Publications and helpful links
General Publications
- Lewis JB, Cunningham SD, Shabanova V, Hassan SS, Magriples U, Rodriguez MG, Ickovics JR. Group prenatal care and improved birth outcomes: Results from a type 1 hybrid effectiveness-implementation study. Prev Med. 2021 Dec;153:106853. doi: 10.1016/j.ypmed.2021.106853. Epub 2021 Oct 20.
- Cunningham SD, Lewis JB, Thomas JL, Grilo SA, Ickovics JR. Expect With Me: development and evaluation design for an innovative model of group prenatal care to improve perinatal outcomes. BMC Pregnancy Childbirth. 2017 May 18;17(1):147. doi: 10.1186/s12884-017-1327-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1304011772
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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