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Expanded NIPT for Pregnancy Complications

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ClinicalTrials.gov Identifier: NCT04311749
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment
Fetal Growth Restriction Preeclampsia Severe Genetic: Expanded panel cell free DNA testing (non-invasive prenatal testing) Genetic: Placental biopsy Genetic: Umbilical cord blood

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Expanded Panel Non-Invasive Prenatal Testing in Identifying Rare Autosomal Trisomies in Pregnancies With Placentally-Mediated Complications
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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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
Severe preeclampsia 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
Low PAPP-A 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
Healthy control 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


Outcome Measures
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Primary Outcome Measures :
  1. Composite adverse pregnancy outcome [ Time Frame: Through study completion, an average of 2 years ]

Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
  • Maternal blood
  • Placental biopsies
  • Umbilical cord blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
This study includes separate cohorts of pregnant women with placentally-mediated complications (fetal growth restriction, severe preeclampsia, and low PAPP-A levels), as well as a cohort of healthy pregnant women with no pregnancy complications.
Criteria

Inclusion Criteria:

  • For fetal growth restriction cohort: 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
  • For severe preeclampsia cohort: diagnosis of early onset (< 34 weeks) preeclampsia with severe features, diagnosed by ACOG criteria
  • For low PAPP-A cohort, diagnosis of low PAPP-A levels (pregnancy associated plasma protein A), defined as less than 0.2 multiples of the median
  • For healthy cohort, normal pregnancy with no evidence of maternal, obstetrical, or fetal complications

Exclusion Criteria:

  • Maternal age < 18 years
  • Multifetal gestation
  • Chronic hypertension
  • Tobacco or drug use
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311749


Contacts
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Contact: Nasim Sobhani, MD (415) 502-3231 Nasim.Sobhani@UCSF.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Nasim C Sobhani, MD    415-502-3231    Nasim.Sobhani@UCSF.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Nasim Sobhani, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04311749    
Other Study ID Numbers: 19-27769
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
 Fetal Diseases
Growth Disorders
Pathologic Processes