Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorDevyser Inc.

About this trial

The purpose of this research is to collect blood samples and data from pregnant women who are Rh negative. The blood will be used for the future research and the development of non-invasive prenatal tests to identify Rh blood type status of the baby during pregnancy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide written informed consent

18 years of age or older at enrollment

Women with a viable pregnancy (with documented fetal heartbeat) between 12 weeks, 0 days and 28 weeks, 0 days gestational age

Women with RhD negative antigen status by serology

Disqualifiers

None

Trial population

Pregnant women who are RhD negative and between 12 and 28 weeks gestation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: Pregnant women

Trial outcomes

Primary outcomes

1

Fetal RhD determination from maternal whole blood

Collected samples will be used for future development of non-invasive prenatal test to determine fetal RhD status from maternal whole blood

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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