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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04311749
Other study ID # 19-27769
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 12, 2020
Est. completion date December 31, 2023

Study information

Verified date March 2023
Source University of California, San Francisco
Contact Nasim Sobhani, MD
Phone (415) 502-3231
Email Nasim.Sobhani@UCSF.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - For fetal growth restriction cohort: 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 - For severe preeclampsia cohort: diagnosis of early onset (< 34 weeks) preeclampsia with severe features, diagnosed by ACOG criteria - For low PAPP-A cohort, diagnosis of low PAPP-A levels (pregnancy associated plasma protein A), defined as less than 0.2 multiples of the median - For healthy cohort, normal pregnancy with no evidence of maternal, obstetrical, or fetal complications Exclusion Criteria: - Maternal age < 18 years - Multifetal gestation - Chronic hypertension - Tobacco or drug use

Study Design


Intervention

Genetic:
Expanded panel cell free DNA testing (non-invasive prenatal testing)
Maternal blood sampling
Placental biopsy
Post-delivery placental sampling
Umbilical cord blood
Post-delivery umbilical cord blood sampling

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite adverse pregnancy outcome Through study completion, an average of 2 years
Secondary Preterm birth < 34 weeks Through study completion, an average of 2 years
Secondary Neonatal intensive care unit admission Through study completion, an average of 2 years
Secondary Intrauterine fetal demise Death of fetus prior to delivery Through study completion, an average of 2 years
Secondary Neonatal demise Death of infant within 28 days of birth Through study completion, an average of 2 years
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