Research On Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS) (NCT07745101) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Research On Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)
United States7,000 participantsStarted 2026-08-01
Plain-language summary
The primary objective of the Stillbirth Research Consortium (SBRC) longitudinal cohort study is to develop and evaluate a robust multivariable prediction model to identify pregnancies at \<14 weeks gestation that are at increased risk of stillbirth or fetal growth restriction (FGR), often reflecting underlying placental dysfunction.
Secondary objectives include:
* To evaluate placental pathology among cases and selected controls using standardized Amsterdam criteria.
* To identify key aspects of perinatal nutrition contributing to placental dysfunction
* To determine relationships between maternal biomarkers, placental pathology and energetics, with the goal of identifying biomarkers predictive of placental dysfunction
* To develop a risk stratification model for pregnancies complicated by decreased fetal movements (DFM)
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Early Pregnancy Cohort Inclusion Criteria
* 18 years of age
* Gestational age at enrollment: Between 12.0 and 13.6 weeks of gestation
* Pregnant individuals receiving care at participating clinical sites with intent of delivering at study hospital
* Consent to participate in study procedures through 6 weeks postpartum
Late Pregnancy Cohort
* 18 years or older
* Gestational age at enrollment: greater than or equal to 28.0 weeks gestational age
* Clinical indications of risk FGR \<10th percentile or report of decreased fetal movement)
* Pregnant individual receiving care at participating clinical sites with intent of delivering at study hospital
* Consent to participate in study procedures through 6 weeks postpartum
Exclusion Criteria:
* Evidence of fetal genetic anomaly or major structural malformation
* Known fetal aneuploidy based on chorionic villus sampling
* Positive cell-free fetal DNA screening for aneuploidy
* Multifetal gestation
* Less than 18 years of age
* Not fluent in either English or Spanish
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome is a composite outcome of stillbirth or severe placental dysfunction, defined as the occurrence of birth at or beyond 20.0 weeks of gestation.