Expanded NIPT for Pregnancy Complications

NCT04311749 | Completed

• 1 other identifier: 19-27769
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Growth Restriction; Preeclampsia Severe

Outcome Measures

Primary Outcomes (1)

• Composite adverse pregnancy outcome

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• 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

• Neonatal demise

  Through study completion, an average of 2 years

Study Arms (1)

Fetal growth restriction

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

Interventions

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

Maternal blood sampling

Fetal growth restriction

Placental biopsy GENETIC

Post-delivery placental sampling

Fetal growth restriction

Umbilical cord blood GENETIC

Post-delivery umbilical cord blood sampling

Fetal growth restriction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study includes pregnant women diagnosed with severe, early onset, unexplained fetal growth restriction.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Maternal blood * Placental biopsies * Umbilical cord blood

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nasim Sobhani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 17, 2020
• Study Start: February 12, 2020
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)