Development of a Fetal Sex Assay From Maternal Whole Blood

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Fetal Sex Determination

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant females

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

No interventions assigned to this group

Eligibility Criteria

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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