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Screening for Hemoglobinopathies in Pregnant Women

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ClinicalTrials.gov Identifier: NCT04029142
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date July 17, 2019
First Posted Date July 23, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date July 3, 2019
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2019)
identification of hemoglobinopathies [ Time Frame: single time point assessment at baseline ]
identification of hemoglobinopathies by investigating routine lab samples
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening for Hemoglobinopathies in Pregnant Women
Official Title Screening for Hemoglobinopathies in Pregnant Women
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population pregnant women seen at the Frauenklinik at University Hospital Basel
Condition Hemoglobinopathies
Intervention Diagnostic Test: Review of routine lab data
Review of routine lab data from pregnant women (first trimester)
Study Groups/Cohorts Not Provided
Publications * Amstad Bencaiova G, Geissler F, Hoesli I. Cohort profile: targeted antenatal screening for haemoglobinopathies in Basel. BMJ Open. 2020 Jul 22;10(7):e035735. doi: 10.1136/bmjopen-2019-035735.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 22, 2019)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • pregnant women seen at the Frauenklinik at University Hospital Basel

Exclusion Criteria:

  • pregnant women with already known hemoglobinopathy
  • refusal of participation
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04029142
Other Study ID Numbers 2019-01065; sp19Amstad
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators Not Provided
Investigators
Principal Investigator: Irene Hoesli, Prof. Dr. Frauenklinik Universitätsspital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date September 2020