Status:

RECRUITING

Prenatal Sonographic Prediction of Placental Histology and Function

Lead Sponsor:

Endeavor Health

Conditions:

Pregnancy Complications

Eligibility:

FEMALE

18-60 years

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.

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 inju...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 28 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2026

    Estimated Enrollment :

    320 Patients enrolled

    Trial Details

    Trial ID

    NCT06022458

    Start Date

    May 28 2024

    End Date

    March 1 2026

    Last Update

    July 31 2025

    Active Locations (1)

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    NorthShore University HealthSystem

    Evanston, Illinois, United States, 60201