Skip to main content
OpenTrials
Completed

NCT Number: NCT04311749

Expanded NIPT for Pregnancy Complications

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Genetic

Maternal blood sampling

Placental biopsy

Genetic

Post-delivery placental sampling

Umbilical cord blood

Genetic

Post-delivery umbilical cord blood sampling

Primary outcomes

  1. Composite adverse pregnancy outcome

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Preterm birth < 34 weeks

    Time frame: Through study completion, an average of 2 years

  2. Neonatal intensive care unit admission

    Time frame: Through study completion, an average of 2 years

  3. Intrauterine fetal demise

    Time frame: Through study completion, an average of 2 years

    Death of fetus prior to delivery

  4. Neonatal demise

    Time frame: Through study completion, an average of 2 years

    Death of infant within 28 days of birth

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2020
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.