Development of a Fetal Sex Assay From Maternal Whole Blood

S

Sequenom

Status

Completed

Conditions

Fetal Sex Determination

Study type

Observational

Funder types

Industry

Identifiers

NCT00970047
SQNM-FS-101

Details and patient eligibility

About

Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.

Full description

This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is 18-64 years of age
  • Subject is female
  • Subject is pregnant and between 6 and 16 weeks of gestation
  • Subject provides a signed and dated informed consent
  • If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results
  • If subject undergoes an invasive procedure, she agrees to provide the fetal sex results

Exclusion criteria

None

Trial design

500 participants in 1 patient group

Pregnant females
Description:
Women who are pregnant and between 6 and 16 weeks of gestation and who are 18 to 64 years of age.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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