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Routine Fetal RhD Genotyping for RhD- Pregnant Women

NCT00832962 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2532

Last updated 2015-03-26

No results posted yet for this study

Summary

The study is divided in two sub-studies. The first one is an economical and performance comparison between two antenatal management strategies of RhD negative pregnant women: the first one will comprise non invasive RhD fetal typing during the second trimester of pregnancy (GENIFERH 1 RhD typing group), and the second will be a conventional management, i.e. without RHD fetal typing (GENIFERH 1 control group). The two groups will consist of 13 maternity wards spread over French territory. The second study (GENIFERH 2) is an evaluation of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal practice with development of knew technical support; it will be based on more than 3500 fetal genotypings performed during one year by the five laboratories participating at the two studies.

Conditions

  • Rhesus Negative Pregnant Women

Interventions

GENETIC

Genotyping

Whole blood sample

OTHER

Usual prophylaxis

Prophylactic anti-RhD

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yves BROSSARD, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832962 on ClinicalTrials.gov