Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data Collection Throughout Pregnancy and Delivery.
- Who it may be relevant to
- Registry conditions: Stillbirth, Placental Insufficiency. Basic parameters: 15 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Utility of a Predictive Model of Placental Insufficiency
Overview
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.
Interventions
- Other Data Collection Throughout Pregnancy and Delivery
Participants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected.
Primary outcome measures
- Number of participants with placental insufficiency composite [Time frame: At time of delivery to 28 days following delivery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT07144839 · STUDY00026808 · 1R01HD115604-01