PregnancyNCT02169024
Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
A study testing Expect With Me group prenatal care and Standard individual prenatal care in people with Pregnancy and Premature Birth, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Premature Birth, Infant, Low Birth Weight
- What is being tested?
- Expect With Me group prenatal care and Standard individual prenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,402 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- less than 24 weeks pregnant
- able to attend groups conducted in English or Spanish
- consent to share their data with the study
Who cannot join
- severe medical problem requiring individual care only, as determined by the participating clinical practice
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wayne State University
Detroit, Michigan, 48201
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
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.
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.
Read more
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.
Read the 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)
- Conditions
- Pregnancy, Premature Birth, Infant, Low Birth Weight, Postpartum Period, Sexually Transmitted Diseases
- Being tested
- Expect With Me group prenatal care, Standard individual prenatal care
- Keywords
- prenatal care, group care, Expect With Me, evaluation studies, group prenatal care
- Medical subject headings
- Premature Birth, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expect With Me group prenatal careBehavioural
Also called 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.
Standard individual prenatal careOther
Also called Individual Care Only
Standard of care- individual prenatal care
| Study group | Role | What they receive |
|---|---|---|
| Expect With Me group prenatal care | Experimental | receiving prenatal care through an Expect With Me group Receives: Behavioral: Expect With Me group prenatal care |
| Individual Care Only | Active comparator | Standard of Care- individual prenatal care Receives: Other: Standard individual prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of preterm birth incidence
Incidence risk of delivery before 37 weeks gestation
Measured: up to 37 weeks gestation
Risk of low birth weight incidence
Incidence risk of infant weight at birth < 2500 grams
Measured: delivery
Risk of small for gestational age incidence
Incidence risk of infant weight below the 10th percentile for the gestational age at birth
Measured: delivery
Risk of neonatal intensive care unit (NICU) admission incidence
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
Measured: birth
Secondary outcomes (17)
breastfeeding
initiation and duration of breastfeeding
Measured: 6 and 12 months postpartum
nutrition
nutritional choices, food security, and use of mindful eating practices
Measured: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
physical activity
level of physical activity in a typical week
Measured: 2nd and 3rd trimester and 6 and 12 months postpartum
readiness for labor and delivery
readiness for labor and delivery
Measured: measured at 2nd and third trimester
readiness for taking care of baby
readiness for taking care of baby
Measured: 2nd and 3rd trimester of pregnancy
social support
multidimensional scale of perceived social support subscale
Measured: 2nd and 3rd trimester and 6 and 12 months postpartum
condom use self-efficacy
condom use self efficacy scale
Measured: 2nd and 3rd trimester and 6 and 12 months postpartum
substance use
use of cigarettes, alcohol, and drugs
Measured: 2nd and 3rd trimester and 6 and 12 months postpartum
care satisfaction
satisfaction with Expect With Me group prenatal care and use of program components
Measured: 3rd trimester
adherence to medical recommendations
adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
Measured: 6 & 12 months postpartum
postpartum body mass index
individual's body weight divided by the square of their height (kg/m2)
Measured: measured at 6 and 12 months postpartum
maternal weight gain
weight gain as compared to medical recommendations
Measured: measured at 2nd and 3rd trimester and birth
mode of delivery
mode of delivery (e.g., cesarean, vaginal)
Measured: delivery
sexual risk: condom use
condom use percent (0-100%)
Measured: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: contraceptive use (LARC)
use of other contraceptives to prevent pregnancy (no/yes)
Measured: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: number of sexual partners
number of partners
Measured: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: sexually transmitted infection
sexually transmitted infection (no/yes, during pregnancy or incident postpartum)
Measured: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Expect With Me group prenatal care vs. Individual Care Only prenatal care
- Masking
- None (open label)
- Enrolment
- 2,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- United Health Foundation
- Responsible party
- Sponsor
- Investigators
- Jeannette R Ickovics, Ph.D., Principal investigator, Yale School of Public HealthJessica B Lewis, PhD, MFT, Study director, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169024
- Sponsor's protocol ID
- 1304011772
- Status last verified
- May 2020
- First submitted
- 18 Jun 2014
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masters C, Carandang RR, Lewis JB, Hagaman A, Metrick R, Ickovics JR, Cunningham SD. Group prenatal care successes, challenges, and frameworks for scaling up: a case study in adopting health care innovations. Implement Sci Commun. 2024 Mar 4;5(1):20. doi: 10.1186/s43058-024-00556-1.
PubMed 38439113Lewis 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.
PubMed 34678329Cunningham 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.
PubMed 28521785
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
- ClinicalTrials.gov ID
- NCT02169024
- Acronym / sponsor ID
- 1304011772
- Conditions
- Pregnancy, Premature Birth, Infant, Low Birth Weight, Postpartum Period, Sexually Transmitted Diseases
- Keywords
- prenatal care, group care, Expect With Me, evaluation studies, group prenatal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,402 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- United Health Foundation
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Expect With Me group prenatal care vs. Individual Care Only prenatal care
| Arm | Type | Receives |
|---|---|---|
| Expect With Me group prenatal care | Experimental | Behavioral: Expect With Me group prenatal carereceiving prenatal care through an Expect With Me group |
| Individual Care Only | Active comparator | Other: Standard individual prenatal careStandard of Care- individual prenatal care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- less than 24 weeks pregnant
- able to attend groups conducted in English or Spanish
- consent to share their data with the study
Key exclusion criteria (1 listed)
- severe medical problem requiring individual care only, as determined by the participating clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expect With Me group prenatal careAlso: group prenatal careExpect 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. | Behavioural | Expect With Me group prenatal care |
| Standard individual prenatal careAlso: Individual Care OnlyStandard of care- individual prenatal care | Other | Individual Care Only |
Primary outcome
Risk of preterm birth incidence
Time frame: up to 37 weeks gestation
Incidence risk of delivery before 37 weeks gestation
Risk of low birth weight incidence
Time frame: delivery
Incidence risk of infant weight at birth < 2500 grams
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
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
17 secondary outcomes
breastfeeding
Time frame: 6 and 12 months postpartum
nutrition
Time frame: 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
readiness for labor and delivery
Time frame: measured at 2nd and third trimester
readiness for taking care of baby
Time frame: 2nd and 3rd trimester of pregnancy
social support
Time frame: 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
substance use
Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum
care satisfaction
Time frame: 3rd trimester
adherence to medical recommendations
Time frame: 6 & 12 months postpartum
postpartum body mass index
Time frame: measured at 6 and 12 months postpartum
maternal weight gain
Time frame: measured at 2nd and 3rd trimester and birth
mode of delivery
Time frame: delivery
sexual risk: condom use
Time frame: 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
sexual risk: number of sexual partners
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 38439113Masters C, Carandang RR, Lewis JB, Hagaman A, Metrick R, Ickovics JR, Cunningham SD. Group prenatal care successes, challenges, and frameworks for scaling up: a case study in adopting health care innovations. Implement Sci Commun. 2024 Mar 4;5(1):20. doi: 10.1186/s43058-024-00556-1.
- Derived from this study: PubMed 34678329Lewis 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.
- Derived from this study: PubMed 28521785Cunningham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannette R Ickovics, Ph.D. principal investigator
Yale School of Public Health
Jessica B Lewis, PhD, MFT study director
Yale School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expect With Me group prenatal care and Standard individual prenatal care in people with Pregnancy and Premature Birth, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of preterm birth incidence (time frame: up to 37 weeks gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02169024, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.