Recruiting

Observational Study

Sponsor:

Endeavor Health

Code:

NCT06022458

Conditions

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06022458

Start date

May 28, 2024

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

320 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Central contacts

Sunitha Suresh

8475702860SSuresh@northshore.org

Camilla Lee

(847) 570-4729JLee5@northshore.org

Locations

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

More Information

Sponsor

Endeavor Health

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • placenta pathology
  • adverse pregnancy outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-07-23.