Prenatal Sonographic Prediction of Placental Histology and Function

NCT06022458 | Recruiting DMC

• 1 other identifier: EH23-068
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications

Keywords

placenta pathology; adverse pregnancy outcomes

Outcome Measures

Primary Outcomes (1)

• Imaging characteristics

  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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Only patients of the female sex will be recruited and a large majority will identify as female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant patients who plan to deliver at NorthShore University HealthSystem

You may qualify if:

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

You may not qualify if:

• Multiple gestation
• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sunitha Suresh

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunitha Suresh

CONTACT

8475702860; SSuresh@northshore.org

Camilla Lee

CONTACT

(847) 570-4729; JLee5@northshore.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, FPA

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 1, 2023
• Study Start: May 28, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)