Expanded NIPT for Pregnancy Complications

NCT ID: NCT04311749

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2024-08-30

Brief Summary

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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

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Conditions

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Fetal Growth Restriction Preeclampsia Severe

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fetal growth restriction

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

Intervention Type GENETIC

Maternal blood sampling

Placental biopsy

Intervention Type GENETIC

Post-delivery placental sampling

Umbilical cord blood

Intervention Type GENETIC

Post-delivery umbilical cord blood sampling

Interventions

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

Maternal blood sampling

Intervention Type GENETIC

Placental biopsy

Post-delivery placental sampling

Intervention Type GENETIC

Umbilical cord blood

Post-delivery umbilical cord blood sampling

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nasim Sobhani, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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19-27769

Identifier Type: -

Identifier Source: org_study_id

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