Prenatal Sonographic Prediction of Placental Histology and Function (NCT06022458) | Clinical Trial Compass
RecruitingNot Applicable
Prenatal Sonographic Prediction of Placental Histology and Function
United States320 participantsStarted 2024-05-28
Plain-language summary
The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery.
Who can participate
Age range
18 Years – 60 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.
Retrospective Phase
Inclusion criteria:
* Patients with delivery in NorthShore University HealthSystem,
* Ultrasound available within 4 weeks of delivery with adequate placental images
* Placental pathology available
Exclusion criteria:
* Multiple gestation
Prospective Phase Inclusion criteria
* Exposed: Patients with singleton gestation with fetal growth restriction at 20-28 weeks with a plan to deliver at NorthShore Highland Park Hospital Evanston Hospital. Patients must have a first-trimester ultrasound (\<14 weeks) to confirm pregnancy dating available in the electronic medical record.
* Unexposed: Patients who present for routine ultrasound evaluation at 36-38 weeks with normal fetal growth with a plan to deliver at NorthShore Highland Park Hospital or NorthShore Evanston Hospital.
Exclusion criteria:
* Exposed: Multiple gestation, major fetal anomaly
* Unexposed: Multiple gestation, history of chronic hypertension, gestational or pregestational diabetes, major fetal anomaly antiphospholipid syndrome, known thrombophilia
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
Imaging characteristics
Timeframe: Image characteristics will be collected every 2 weeks prenatally, and placenta will be collected at the time of delivery for analysis, this will be up to 22 weeks