Pregnancy ComplicationsNCT06022458
Prenatal Sonographic Prediction of Placental Histology and Function
An observational study of Pregnancy Complications, run by Endeavor Health at 1 site in United States.
Trial summary
The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to Mar 2027
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients who plan to deliver at NorthShore University HealthSystem
Who may be able to join
- Patients with delivery in NorthShore University HealthSystem,
- Ultrasound available within 4 weeks of delivery with adequate placental images
- Placental pathology available
Who cannot join
- Multiple gestation
- Prospective Phase Inclusion criteria
- Exposed: Patients with singleton gestation with fetal growth restriction at 20-28 weeks with a plan to deliver at NorthShore Highland Park Hospital Evanston Hospital. Patients must have a first-trimester ultrasound (<14 weeks) to confirm pregnancy dating available in the electronic medical record.
- Unexposed: Patients who present for routine ultrasound evaluation at 36-38 weeks with normal fetal growth with a plan to deliver at NorthShore Highland Park Hospital or NorthShore Evanston Hospital.
- Exposed: Multiple gestation, major fetal anomaly
- Unexposed: Multiple gestation, history of chronic hypertension, gestational or pregestational diabetes, major fetal anomaly antiphospholipid syndrome, known thrombophilia
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
NorthShore University HealthSystem
Evanston, Illinois, 60201
Sunitha Suresh, MD
About this study
The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery.
Read the detailed description
Placenta pathology is examined at the time of delivery and can show the underlying pathophysiology of adverse pregnancy outcomes. The Amsterdam consensus has identified four primary categories of injury, acute inflammation, fetal vascular malperfusion, maternal vascular malperfusion, and chronic inflammation associated with adverse obstetric outcomes. Findings from placental pathologic examination performed at delivery can reveal important patterns of injury that lead to adverse pregnancy outcomes but cannot aid in preventing these outcomes. Ultrasound of the placenta may be able to detect placental pathology in the antepartum period to potentially aid in detection and treatment of placental injury. One specific scenario it may be useful in is in the setting of fetal growth restriction, which can be constitutional or pathologic. Identification of growth restriction in the setting of placental injury may identify those patients at greatest risk for adverse outcomes.
In the retrospective portion of this study, researchers will retrospectively evaluate archived ultrasonographic images during pregnancies affected by stillbirth, severe placental histology, fetal growth restriction, and milder histologic abnormalities. The goal of this phase is to develop image processing of placentas and to utilize the image processing of existing sonograms to correlate with the presence or absence of placental pathology at the time of delivery.
The prospective portion of this study the researchers will utilize image processing techniques from the initial phase to prospectively assess placental function. The goal of this phase is to evaluate if placental size, vasculature, and echogenicities among fetuses with suspected growth restriction are associated with maternal vascular mal perfusion on placental pathology. Twenty patients with fetal growth restriction by estimated fetal weight (EFW) < 10th percentile or fetal abdominal circumference (AC) < 10th percentile and EFW < 20th percentile will be recruited as the exposure group. Participants who consent will complete sonographic measurements of the placenta, predefined image capture of color flow to the placenta, and grayscale images every two weeks. Another twenty patients without SGA (small for gestational age) or significant comorbidities will be recruited in the unexposed control group. Upon consenting, these participants will complete sonographic measurements of the placenta for one time. For both groups, information will be abstracted from electronic medical records regarding demographic data, neonatal outcomes, and placental histology. Imaging characteristics will be compared by placental histology and grade of histology at delivery. As this is a pilot project, there is not an a priori power analysis.
- Conditions
- Pregnancy Complications
- Keywords
- placenta pathology, adverse pregnancy outcomes
- Medical subject headings
- Pregnancy Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging characteristics
Imaging characteristics will be compared by those with and without placental pathology found at the time of delivery
Measured: Image characteristics will be collected every 2 weeks prenatally, and placenta will be collected at the time of delivery for analysis, this will be up to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start28 May 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunitha Suresh, Endeavor Health
- Investigators
- Sunitha Suresh, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022458
- Sponsor's protocol ID
- EH23-068
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Sonographic Prediction of Placental Histology and Function
- ClinicalTrials.gov ID
- NCT06022458
- Acronym / sponsor ID
- EH23-068
- Conditions
- Pregnancy Complications
- Keywords
- placenta pathology, adverse pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Sep 2023 (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.
The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery.
Detailed description
Placenta pathology is examined at the time of delivery and can show the underlying pathophysiology of adverse pregnancy outcomes. The Amsterdam consensus has identified four primary categories of injury, acute inflammation, fetal vascular malperfusion, maternal vascular malperfusion, and chronic inflammation associated with adverse obstetric outcomes. Findings from placental pathologic examination performed at delivery can reveal important patterns of injury that lead to adverse pregnancy outcomes but cannot aid in preventing these outcomes. Ultrasound of the placenta may be able to detect placental pathology in the antepartum period to potentially aid in detection and treatment of placental injury. One specific scenario it may be useful in is in the setting of fetal growth restriction, which can be constitutional or pathologic. Identification of growth restriction in the setting of placental injury may identify those patients at greatest risk for adverse outcomes.
In the retrospective portion of this study, researchers will retrospectively evaluate archived ultrasonographic images during pregnancies affected by stillbirth, severe placental histology, fetal growth restriction, and milder histologic abnormalities. The goal of this phase is to develop image processing of placentas and to utilize the image processing of existing sonograms to correlate with the presence or absence of placental pathology at the time of delivery.
The prospective portion of this study the researchers will utilize image processing techniques from the initial phase to prospectively assess placental function. The goal of this phase is to evaluate if placental size, vasculature, and echogenicities among fetuses with suspected growth restriction are associated with maternal vascular mal perfusion on placental pathology. Twenty patients with fetal growth restriction by estimated fetal weight (EFW) < 10th percentile or fetal abdominal circumference (AC) < 10th percentile and EFW < 20th percentile will be recruited as the exposure group. Participants who consent will complete sonographic measurements of the placenta, predefined image capture of color flow to the placenta, and grayscale images every two weeks. Another twenty patients without SGA (small for gestational age) or significant comorbidities will be recruited in the unexposed control group. Upon consenting, these participants will complete sonographic measurements of the placenta for one time. For both groups, information will be abstracted from electronic medical records regarding demographic data, neonatal outcomes, and placental histology. Imaging characteristics will be compared by placental histology and grade of histology at delivery. As this is a pilot project, there is not an a priori power analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients who plan to deliver at NorthShore University HealthSystem
Key inclusion criteria (3 listed)
- Patients with delivery in NorthShore University HealthSystem,
- Ultrasound available within 4 weeks of delivery with adequate placental images
- Placental pathology available
Key exclusion criteria (6 listed)
- Multiple gestation
- Prospective Phase Inclusion criteria
- Exposed: Patients with singleton gestation with fetal growth restriction at 20-28 weeks with a plan to deliver at NorthShore Highland Park Hospital Evanston Hospital. Patients must have a first-trimester ultrasound (<14 weeks) to confirm pregnancy dating available in the electronic medical record.
- Unexposed: Patients who present for routine ultrasound evaluation at 36-38 weeks with normal fetal growth with a plan to deliver at NorthShore Highland Park Hospital or NorthShore Evanston Hospital.
- Exposed: Multiple gestation, major fetal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Imaging characteristics
Time frame: Image characteristics will be collected every 2 weeks prenatally, and placenta will be collected at the time of delivery for analysis, this will be up to 22 weeks
Imaging characteristics will be compared by those with and without placental pathology found at the time of delivery
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 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sunitha Suresh principal investigator
Endeavor Health
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 Pregnancy Complications, run by Endeavor Health 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 3 inclusion and 6 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 23 Jul 2026. 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 Sunitha Suresh (8475702860, SSuresh@northshore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging characteristics (time frame: Image characteristics will be collected every 2 weeks prenatally, and placenta will be collected at the time of delivery for analysis, this will be up to 22 weeks). 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 23 Jul 2026.