Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT07144839

Conditions

Stillbirth

Placental Insufficiency

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

Interventions

Data Collection Throughout Pregnancy and Delivery

Study Details

Brief summary:

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

Conditions

Stillbirth

Placental Insufficiency

Study ID

NCT07144839

Start date

Sep 18, 2025

Status verified date

Dec, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

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

Enrollment

640 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational Cohort

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.

Interventions

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 measure

  • Number of participants with placental insufficiency composite [ Time Frame: At time of delivery to 28 days following delivery ]

Central Contacts and Locations

Central contacts

Women's Health Research Unit Department of Ob/Gyn

503-494-3666whru@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Women's Health Research Unit

503-494-3666whru@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-12-17.