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Screening for Hemoglobinopathies in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04029142
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
This prospective monocentric study project is to identify hemoglobinopathies in pregnant women in order to optimize antenatal care and to investigate the prevalence of hemoglobinopathies in pregnant women in Switzerland.

Condition or disease Intervention/treatment
Hemoglobinopathies Diagnostic Test: Review of routine lab data

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Hemoglobinopathies in Pregnant Women
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Review of routine lab data
    Review of routine lab data from pregnant women (first trimester)


Primary Outcome Measures :
  1. identification of hemoglobinopathies [ Time Frame: single time point assessment at baseline ]
    identification of hemoglobinopathies by investigating routine lab samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
pregnant women seen at the Frauenklinik at University Hospital Basel
Criteria

Inclusion Criteria:

  • pregnant women seen at the Frauenklinik at University Hospital Basel

Exclusion Criteria:

  • pregnant women with already known hemoglobinopathy
  • refusal of participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029142


Contacts
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Contact: Gabriela Amstad Bencaiova, Dr. med 0041 61 556 5922 gabriela.amstad@usb.ch
Contact: Irene Hoesli, Prof. Dr. 0041 61 265 9017 irene.hoesli@usb.ch

Locations
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Switzerland
Frauenklinik University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Gabriela Amstad Bencaiova, Dr. med    +41 61 556 59 22    gabriela.amstad@usb.ch   
Sub-Investigator: Franziska Geissler, Dr.med         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Irene Hoesli, Prof. Dr. Frauenklinik Universitätsspital Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04029142    
Other Study ID Numbers: 2019-01065; sp19Amstad
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
thalassemia
sickle cell anaemia
molecular genetic analysis
Additional relevant MeSH terms:
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Hemoglobinopathies
Hematologic Diseases
Genetic Diseases, Inborn