AI-Based Ultrasound Prediction of Pregnancy Outcomes in Placental-Related Fetal Growth Restrictio… (NCT07473739) | Clinical Trial Compass
RecruitingNot Applicable
AI-Based Ultrasound Prediction of Pregnancy Outcomes in Placental-Related Fetal Growth Restriction (MVM-FGR): A Prospective Cohort Study
China300 participantsStarted 2023-01-01
Plain-language summary
The goal of this prospective cohort study is to enroll pregnancies complicated by placental-related fetal growth restriction (FGR) and to develop predictive models for adverse short- and long-term outcomes. This will be achieved by collecting novel intrauterine monitoring indicators along the fetal brain-placenta-heart axis, combined with conventional fetal surveillance parameters, in order to improve risk stratification and guide clinical management, ultimately improving pregnancy outcomes.
The study will include pregnant women with singleton pregnancies complicated by isolated early-onset placental insufficiency-related FGR, preferably those with abnormal umbilical artery Doppler findings, who elect to continue the pregnancy.
The main question it aims to answer is:
• Whether a predictive model integrating novel intrauterine monitoring indicators along the fetal brain-placenta-heart axis with conventional monitoring parameters can accurately predict perinatal and neonatal adverse outcomes in pregnancies complicated by placental-related FGR.
Who can participate
Age range
20 Years – 43 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.
Inclusion Criteria:
* Singleton pregnancy.
* Isolated early-onset placental insufficiency-related fetal growth restriction (FGR), with priority given to cases with abnormal umbilical artery Doppler flow.
* Pregnancies in which expectant management is continued.
Exclusion Criteria:
* Multiple pregnancy complicated by selective fetal growth restriction (sFGR).
* FGR caused by fetal structural anomalies, genetic abnormalities, or intrauterine infection.
* Twin pregnancy with intrauterine fetal demise (IUFD) of one fetus.
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
pregnancy outcome
Timeframe: during the whole pregnancy and born within 28 days
Trial details
NCT IDNCT07473739
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine