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RecruitingNCT07144839PRACTICEUpdated Dec 17, 2025

Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation

An observational study in Stillbirth and Placental Insufficiency, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Oregon Health and Science University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
640
Ages
15 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Stillbirth
  • Placental Insufficiency
03

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Decisional impairment
  • Multiple gestation
  • Known fetal growth restriction or major congenital anomaly
  • Inability to consent
  • Inability to attend study visits
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
640 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherData 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.

05

What researchers measure

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 delivery

06

Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    • Women's Health Research Unit · Contact · whru@ohsu.edu · 503-494-3666
    Recruiting
07

Registry details

Key details

Study ID
NCT07144839
Lead sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Karen Gibbins (Principal Investigator, Oregon Health and Science University) — Principal investigator
First posted
Aug 28, 2025
Start date
Sep 18, 2025
Primary completion
Jun 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
Dec 17, 2025

Study contacts

Women's Health Research Unit Department of Ob/Gyn
Contact
whru@ohsu.edu
503-494-3666
Karen Gibbins
principal investigator · Oregon Health and Science University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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