Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation

NCT07144839 | Recruiting

• 2 other identifiers: STUDY000268081R01HD115604-01
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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)

  At time of delivery to 28 days following delivery

Study Arms (1)

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.

Other: Data Collection Throughout Pregnancy and Delivery

Interventions

Data Collection Throughout Pregnancy and Delivery OTHER

Participants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected.

Observational Cohort

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Decisional impairment
• Multiple gestation
• Known fetal growth restriction or major congenital anomaly
• Inability to consent
• Inability to attend study visits

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma without DNA will be retained in the OHSU repository for potential future research.

MeSH Terms

Conditions

Stillbirth; Placental Insufficiency

Interventions

Parturition

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Placenta Diseases

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Karen Gibbins

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)