Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation (PRACTICE)

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Stillbirth; Placental Insufficiency

Treatments: Other: Data Collection Throughout Pregnancy and Delivery

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07144839

STUDY00026808

1R01HD115604-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.

Full 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.

Enrollment: 640 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

640 participants in 1 patient group

Observational Cohort

Description:

Pregnant people age 15 and older, without known major fetal anatomic or genetic abnormalities, singleton gestation will be monitored via ultrasound and blood tests throughout pregnancy. Delivery data and neonatal outcomes will be collected. Data will be used to develop a predictive model of placental insufficiency.

Treatment:

Other: Data Collection Throughout Pregnancy and Delivery