ClinicalTrials.gg
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

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 22 studies in Stillbirth with a site in United States — 11 open to participants now, 11 under way, 1 of them phase 3. Stillbirth · United States.

Started
2025
with 3 others
Observational
8 of 22
6 open now
Primary completion
2029-06
later than 8 of 10 live
Registered
19th of 22
by date

Among the 22 studies in Stillbirth with a site in United States, this one is one of 4 that started in 2025, is one of 8 observational ones, reaches primary completion later than 8 of the 10 other live ones, and was the 19th registered.

Stillbirth

121 studies on the registry are indexed under Stillbirth; 34 are open to participants now.

Browse Stillbirth studies →

Open to participants now

11 of the 22 studies in Stillbirth with a site in United States are open now. Recruiting first, the newest first:

5 more — sign in →

All 11 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 24 Stillbirth studies recruiting now, 10 (42%) set no upper age limit and 14 (58%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.

This study: 15 Years to 50 Years · female · no healthy volunteers.

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02

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.

03

Conditions studied

  • Stillbirth
  • Placental Insufficiency
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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.

06

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Jun 2029, 45 months after the start.

Of 30 observational studies under Stillbirth, half reached primary completion within 91 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 122. This study's planned 45 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2025
First posted
Aug 28, 2025
StartActual
Sep 18, 2025
Primary completionEst.
Jun 2029
CompletionEst.
Jun 2029
Last update
Dec 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07144839
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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