Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation
Not yet recruiting
- Conditions
- StillbirthPlacental Insufficiency
- Registration Number
- NCT07144839
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.
- Detailed Description
Pregnant study participants will be recruited and monitored throughout pregnancy with ultrasound and blood draws, and delivery and neonatal data up to 28 days following birth. This data will be used to develop a model to predict placental insufficiency.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 640
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Placental insufficiency composite At time of delivery to 28 days following delivery The composite is made of the following: stillbirth and neonatal death, severe forms of hypertensive disease, placental abruption, birthweight below the 3rd percentile, umbilical cord arterial pH\<7, and/or placental primary indication for delivery (FGR, oligohydramnios, abnormal fetal testing)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Oregon Health & Science University🇺🇸Portland, Oregon, United States