NCT03590678

Brief Summary

To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
6 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

May 4, 2017

Last Update Submit

May 3, 2022

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Collect Whole Blood Specimens in Pregnant Women

    To collect maternal whole blood specimens from approximately 5,150 women with corresponding cytogenetic results from invasive prenatal diagnostic procedures (performed per the standard of care) to achieve sample size goals

    3 years

Study Arms (2)

1

Subject is scheduled for an invasive procedure and did not have NIPT testing in current pregnancy

2

Subject is scheduled for an invasive procedure and has a known positive or no-call result from a targeted NIPT in the current pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with a viable pregnancy of at least 10 weeks, 0 days gestation who are scheduled for an invasive procedure performed per the standard of care.

You may qualify if:

  • Be 18 years of age or older at enrollment,
  • Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days gestation at the time of maternal specimen collection,
  • Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus sampling \[CVS\], amniocentesis, or percutaneous umbilical cord blood sampling \[cordocentesis\]) for cytogenetic analysis of the fetus

You may not qualify if:

  • Has a known maternal chromosomal anomaly,
  • Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal specimen collection
  • Has a history of transplant or malignancy, or
  • Had a transfusion of blood or blood components up to 8 weeks before maternal whole blood specimen collection
  • Already participated in this study (enrolled previously).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Center for Fetal Medicine

Los Angeles, California, 90048, United States

Location

Maternal Fetal Medicine and Genetics

Riverside, California, 92506, United States

Location

Desert Perinatal Associates

Las Vegas, Nevada, 89148, United States

Location

Practice Research Organization

Dallas, Texas, 75230, United States

Location

Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine

Norfolk, Virginia, 23507, United States

Location

Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

Location

Kuala Lumpur Hospital

Kuala Lumpur, Malaysia

Location

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

Location

CENTRUM INNOWACYJNYCH TERAPII Sp. z

Piaseczno, 05-500, Poland

Location

FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA

Warsaw, 00-172, Poland

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

"Institute of general practice - family medicine"

Kyiv, 02132, Ukraine

Location

LLC "Reproductive Genetics Clinic "Victoria"

Kyiv, 04070, Ukraine

Location

Medical Center "Pulse", Small Private Business

Vinnytsia, 21001, Ukraine

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human blood specimens will be spun to plasma and stored at -80C freezers

Study Officials

  • Kathryn Waldrep, MD

    Medical City Dallas Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

July 18, 2018

Study Start

February 13, 2017

Primary Completion

August 30, 2019

Study Completion

December 31, 2019

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)PL(3)TH(3)MY(1)UA(3)US(5)