Expanded NIPT for Pregnancy Complications

University of California San Francisco (UCSF)

Status: Completed

Conditions: Preeclampsia Severe; Fetal Growth Restriction

Treatments: Genetic: Umbilical cord blood; Genetic: Expanded panel cell free DNA testing (non-invasive prenatal testing); Genetic: Placental biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT04311749

19-27769

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Fetal growth restriction

Treatment:

Genetic: Placental biopsy

Genetic: Expanded panel cell free DNA testing (non-invasive prenatal testing)

Genetic: Umbilical cord blood