Routine Fetal RhD Genotyping for RhD- Pregnant Women (GENIFERH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00832962
First received: January 13, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Rhesus Negative Pregnant Women
Genetic: Genotyping
Other: Usual prophylaxis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effectiveness of Routine Fetal RhD Genotyping for RhD- Pregnant Women

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • cost-effectiveness of the two strategies of antenatal management by comparing the rate of RhD negative women eligible for receiving RHIG that would have not receive prophylactic anti-RhD in the two populations, the one with fetal RHD typing and the other [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the applicability of non invasive fetal RHD typing in the antenatal management of unimmunized Rh-negative pregnant patients in different settings. [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • performance assessment of high throughput fetal RHD genotyping in hospital laboratories. [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Evaluation of the technical support needed to realize high throughput fetal RHD genotyping by authorized laboratories. [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Development and diffusion of external quality controls for non invasive fetal RHD genotyping. [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood sample (0.5 ml)


Enrollment: 2532
Study Start Date: January 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Adult Rh negative pregnant patients from 7 selected centers (SAINT ANTOINE hospital, CHU Marseille, CHU Nantes, CHU Lille, LOUIS MOURIER Hospital, SAINT VINCENT-PAUL Hospital, CH POISSY)
Genetic: Genotyping
Whole blood sample
Other Name: Genotyping
2
Adult Rh negative pregnant patients from 6 selected centers (Tenon hospital, Jean VERDIER Hospital, La Pitie-Salpetriere Hospital, Cochin Hospital, Robert Debre Hospital, BICHAT Hospital)
Other: Usual prophylaxis
Prophylactic anti-RhD
Other Name: Prophylactic anti-RhD

Detailed Description:

Alloimmunisation against the RhD (RH) red cell surface antigen is the commonest cause of haemolytic disease of the fetus and newborn. It can be avoided by anti D immunoglobulin administration (RhIg). At the end of year 2005, new recommendations about anti-D prophylaxis in France proposed that all RhD negative pregnant women should be given anti-D immunoglobulin at 28 weeks' gestation. However, about one third of these women would be carrying an RhD negative fetus and would receive the treatment unnecessarily. A non-invasive fetal RHD typing kit, CE labelled since June 2007, is available and could be proposed to all RhD negative pregnant women. Applicable from the end of the first trimester of pregnancy on fetal DNA isolated from maternal plasma, this assay allows RhIg to be specifically injected to unsensitized pregnancies with RhD positive fetus only, and to promote the use of antenatal RhIg prophylaxis in a rational approach with economical and ethical impact.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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult Rh negative pregnant women followed in the participating centers

Criteria

Inclusion Criteria:

  • Adult Rh negative pregnant patients ( ≥ 18 years)
  • Valid and confirmed result of Rh D negative status.(one copy saved into the obstetrical records)
  • Absence of actively produced anti-D antibody as shown on laboratory examination of a blood sample taken within the first trimester of pregnancy.
  • Evolving pregnancy at the time of inclusion in the study ( between 8 and 26 gestation weeks as confirmed by early sonography).
  • Absence of a previous invasive fetal RHD genotyping ( chorionic villous sampling, amniocentesis).
  • Patient having signed an informed consent for the study.
  • Inclusion and delivery expected in the same maternity ward
  • Patient affiliated to a social security regimen.

Exclusion Criteria:

  • Evolving pregnancy seen for the first time after 26 gestation weeks.
  • Poor understanding of the objectives of the study ( language barrier, ...)
  • Delivery expected in a maternity ward not participating at the study.
  • Fetal RHD invasive genotyping performed during early pregnancy on amniotic fluid or chorionic villus.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00832962

Locations
France
Hopital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves BROSSARD, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00832962     History of Changes
Other Study ID Numbers: P 060410, IC 0606
Study First Received: January 13, 2009
Last Updated: March 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rhesus D
Anti-D allo-immunization
Fetal RHD genotyping
anti-D immunoglobulins
anti-D prophylaxis

ClinicalTrials.gov processed this record on September 18, 2014