Expanded NIPT for Pregnancy Complications

Fetal Growth Restriction Clinical Trial

Official title:

The Role of Expanded Panel Non-Invasive Prenatal Testing in Identifying Rare Autosomal Trisomies in Pregnancies With Placentally-Mediated Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04311749
• Other study ID #: 19-27769
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation
• Pre-Eclampsia
• Preeclampsia Severe

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