Status:

COMPLETED

Predicting Placental Pathologies by Ultrasound Imaging

Lead Sponsor:

Mayo Clinic

Conditions:

Intrauterine Growth Restriction

Villitis

Eligibility:

FEMALE

18-45 years

Brief Summary

Intrauterine growth restriction (IUGR) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. It is unclear why IUGR happens, but an increase...

Detailed Description

Intrauterine growth restriction (IUGR) occurs in 3-10% of all pregnancies and is associated with significant morbidity and mortality during pregnancy, after birth and throughout the child's lifespan. ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for IUGR study cohort:
  • Pregnancy \> 28 weeks gestation
  • Diagnosis of Intrauterine Growth Restriction (IUGR) before admission for labor and delivery
  • Weight \> 110 lbs (50 kg)
  • Ability to understand and provide written informed consent
  • Inclusion Criteria for control cohort:
  • Pregnancy \> 28 weeks gestation
  • No known pregnancy complications at prenatal obstetrical visit (+/- 1 week gestational age of matched subject in IUGR cohort)
  • Weight \> 110 lbs (50 kg)
  • Ability to understand and provide written informed consent
  • Exclusion Criteria:
  • Known immunodeficiency or pregnancy complication (i.e. preeclampsia or gestational diabetes)
  • Known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or chronic hypertension
  • Chronic, active viral infections, including HIV-1/2, HTLV-1/2, Hepatitis B or C
  • Solid organ or transplant recipient
  • Current smokers (tobacco exposure within 30 days of registration)
  • Conceptions from assisted reproductive technology (prior Clomid use is allowed)
  • Multiple gestation
  • Ruptured membranes
  • Pregnancy \<28 weeks gestation
  • Not planning on delivering at Mayo Clinic

Exclusion

    Key Trial Info

    Start Date :

    September 27 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 31 2023

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT04506970

    Start Date

    September 27 2020

    End Date

    October 31 2023

    Last Update

    October 10 2024

    Active Locations (1)

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    Mayo Clinic

    Rochester, Minnesota, United States, 55905