Prenatal Sonographic Prediction of Placental Histology and Function

July 22, 2026 updated by: Sunitha Suresh, Endeavor Health
The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Northshore University Healthsystem
        • Contact:
          • Sunitha Suresh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant patients who plan to deliver at NorthShore University HealthSystem

Description

Retrospective Phase

Inclusion criteria:

  • Patients with delivery in NorthShore University HealthSystem,
  • Ultrasound available within 4 weeks of delivery with adequate placental images
  • Placental pathology available

Exclusion criteria:

  • 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.

Exclusion criteria:

  • Exposed: Multiple gestation, major fetal anomaly
  • Unexposed: Multiple gestation, history of chronic hypertension, gestational or pregestational diabetes, major fetal anomaly antiphospholipid syndrome, known thrombophilia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Investigators

  • Principal Investigator: Sunitha Suresh, Endeavor Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH23-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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