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Expanded NIPT for Pregnancy Complications

Completed
Conditions
Preeclampsia Severe
Fetal Growth Restriction
Registration Number
NCT04311749
Lead Sponsor
University of California, San Francisco
Brief Summary

This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
70
Inclusion Criteria
  • Diagnosis of early onset (< 34 weeks) severe fetal growth restriction, defined as estimated fetal weight less than 10th percentile with abnormal umbilical artery Dopplers OR estimated fetal weight less than 5th percentile alone OR biometric size at least 14 days behind expected dates
Exclusion Criteria
  • Maternal age < 18 years
  • Multifetal gestation
  • Chronic hypertension require use of pharmacotherapy
  • Tobacco or drug use
  • Major congenital malformations

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite adverse pregnancy outcomeThrough study completion, an average of 2 years
Secondary Outcome Measures
NameTimeMethod
Preterm birth < 34 weeksThrough study completion, an average of 2 years
Neonatal intensive care unit admissionThrough study completion, an average of 2 years
Intrauterine fetal demiseThrough study completion, an average of 2 years

Death of fetus prior to delivery

Neonatal demiseThrough study completion, an average of 2 years

Death of infant within 28 days of birth

Trial Locations

Locations (1)

University of California, San Francisco

🇺🇸

San Francisco, California, United States

University of California, San Francisco
🇺🇸San Francisco, California, United States

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