StillbirthPRACTICENCT07144839
Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation
An observational study of Stillbirth and Placental Insufficiency, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Stillbirth, Placental Insufficiency
- What is being tested?
- Data Collection Throughout Pregnancy and Delivery
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2025to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Decisional impairment
- Multiple gestation
- Known fetal growth restriction or major congenital anomaly
- Inability to consent
- Inability to attend study visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Women's Health Research Unit, 503-494-3666, whru@ohsu.edu
About this study
Official title: Clinical Utility of a Predictive Model of Placental Insufficiency
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.
- Conditions
- Stillbirth, Placental Insufficiency
- Being tested
- Data Collection Throughout Pregnancy and Delivery
- Medical subject headings
- Stillbirth, Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data Collection Throughout Pregnancy and DeliveryOther
Participants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data Collection Throughout Pregnancy and Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At time of delivery to 28 days following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start18 Sep 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StillbirthStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Karen Gibbins, Oregon Health and Science University
- Investigators
- Karen Gibbins, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144839
- Sponsor's protocol ID
- STUDY00026808
- Other IDs
- 1R01HD115604-01
- Acronym
- PRACTICE
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of a Predictive Model of Placental Insufficiency
- ClinicalTrials.gov ID
- NCT07144839
- Acronym / sponsor ID
- PRACTICE / STUDY00026808
- Conditions
- Stillbirth, Placental Insufficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Other: Data Collection Throughout Pregnancy and DeliveryPregnant 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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- Pregnant
- Age 15 or older
- No known major fetal anatomic or genetic abnormalities
- Singleton gestation
- Planning to deliver at Oregon Health \& Science University
Key exclusion criteria (5 listed)
- Decisional impairment
- Multiple gestation
- Known fetal growth restriction or major congenital anomaly
- Inability to consent
- Inability to attend study visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data Collection Throughout Pregnancy and DeliveryParticipants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected. | Other | Observational Cohort |
Primary outcome
Number of participants with placental insufficiency composite
Time frame: At time of delivery to 28 days following delivery
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Gibbins principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stillbirth and Placental Insufficiency, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with placental insufficiency composite (time frame: At time of delivery to 28 days following delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.