Expanded NIPT for Pregnancy Complications

Completed

• Conditions: Preeclampsia Severe; Fetal Growth Restriction
• Interventions: Genetic: Expanded panel cell free DNA testing (non-invasive prenatal testing); Genetic: Placental biopsy; Genetic: Umbilical cord blood

• 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

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-17
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

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

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Exclusion Criteria

• Maternal age < 18 years
• Multifetal gestation
• Chronic hypertension require use of pharmacotherapy
• Tobacco or drug use
• Major congenital malformations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe preeclampsia	Expanded panel cell free DNA testing (non-invasive prenatal testing)	-
Severe preeclampsia	Umbilical cord blood	-
Low PAPP-A	Umbilical cord blood	-
Fetal growth restriction	Expanded panel cell free DNA testing (non-invasive prenatal testing)	-
Fetal growth restriction	Umbilical cord blood	-
Severe preeclampsia	Placental biopsy	-
Low PAPP-A	Expanded panel cell free DNA testing (non-invasive prenatal testing)	-
Low PAPP-A	Placental biopsy	-
Fetal growth restriction	Placental biopsy	-
Healthy control	Placental biopsy	-
Healthy control	Umbilical cord blood	-
Healthy control	Expanded panel cell free DNA testing (non-invasive prenatal testing)	-

Primary Outcome Measures

Name	Time	Method
Composite adverse pregnancy outcome	Through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
Preterm birth < 34 weeks	Through study completion, an average of 2 years
Neonatal intensive care unit admission	Through study completion, an average of 2 years
Intrauterine fetal demise	Through study completion, an average of 2 years	Death of fetus prior to delivery
Neonatal demise	Through 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