Personalized placental risk assessment to customize pregnancy care
Clinical Utility of a Predictive Model of Placental Insufficiency
This project will try to build a tool that uses pregnancy ultrasound and blood tests to predict placental insufficiency for people with a single pregnancy who plan to deliver at OHSU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 640 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT07144839 on ClinicalTrials.gov |
What this trial studies
This prospective observational study enrolls pregnant participants before 22 weeks' gestation and follows them through delivery and the neonatal period up to 28 days. Participants will undergo scheduled ultrasounds and blood draws during pregnancy, and clinical delivery and newborn data will be collected. The combined imaging, laboratory, and clinical data will be used to develop and validate a predictive model of placental insufficiency. The aim is to identify pregnancies at higher risk for placental dysfunction so care can be tailored earlier.
Who should consider this trial
Good fit: Pregnant people aged 15 or older with a singleton pregnancy, no known major fetal anomalies, enrolling before 22 weeks and planning to deliver at Oregon Health & Science University are ideal candidates.
Not a fit: People with multiple gestations, known major fetal or genetic anomalies, inability to attend study visits, or those planning delivery outside OHSU are unlikely to benefit from this specific program.
Why it matters
Potential benefit: If successful, the tool could identify pregnancies at risk for placental insufficiency earlier so clinicians can tailor monitoring or delivery plans to reduce adverse outcomes.
How similar studies have performed: Previous work combining ultrasound measures and blood biomarkers has shown promise for predicting placental problems, but no single widely adopted predictive model currently exists.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant * Age 15 or older * No known major fetal anatomic or genetic abnormalities * Singleton gestation * Planning to deliver at Oregon Health \& Science University * Prior to 22 weeks' gestation Exclusion Criteria: * Decisional impairment * Multiple gestation * Known fetal growth restriction or major congenital anomaly * Inability to consent * Inability to attend study visits
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Karen Gibbins — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Department of Ob/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.