Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-50
SponsorOregon Health and Science University
About this trial
This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant
Age 15 or older
No known major fetal anatomic or genetic abnormalities
Singleton gestation
Disqualifiers
Decisional impairment
Multiple gestation
Known fetal growth restriction or major congenital anomaly
Inability to consent
Trial population
Pregnant people age 15 and older, parous and nulliparous, without known major fetal anatomic or genetic abnormalities. Participants must be pregnant with a singleton living gestation, less than 22 weeks' gestation at enrollment, and planning to deliver at Oregon Health \& Science University.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data Collection Throughout Pregnancy and Delivery
Other interventionParticipants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected.
Treatment groups
640 Participants
are divided into 1 treatment groupGroup A: Observational Cohort1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with placental insufficiency composite
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)
Time frame
At time of delivery to 28 days following deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov