Expanded NIPT for Pregnancy Complications

October 16, 2024 updated by: University of California, San Francisco

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fetal growth restriction
Genetic: Expanded panel cell free DNA testing (non-invasive prenatal testing)
Maternal blood sampling
Genetic: Placental biopsy
Post-delivery placental sampling
Genetic: Umbilical cord blood
Post-delivery umbilical cord blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite adverse pregnancy outcome
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm birth < 34 weeks
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Neonatal intensive care unit admission
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Intrauterine fetal demise
Time Frame: Through study completion, an average of 2 years
Death of fetus prior to delivery
Through study completion, an average of 2 years
Neonatal demise
Time Frame: Through study completion, an average of 2 years
Death of infant within 28 days of birth
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Nasim Sobhani, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-27769

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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