Screening for Hemoglobinopathies in Pregnant Women

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04029142
• Collaborator: (none)
• Enrollment: 1,500
• Location: 1
• Anticipated Duration (Months): 74
• Patients Per Site Per Month: 20.3

Study Details

Study Description

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	Phase
Hemoglobinopathies	Diagnostic Test: Review of routine lab data

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Screening for Hemoglobinopathies in Pregnant Women
• Actual Study Start Date: Jul 3, 2019
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Sep 1, 2025

Outcome Measures

Primary Outcome Measures

1. identification of hemoglobinopathies [single time point assessment at baseline]

   identification of hemoglobinopathies by investigating routine lab samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• pregnant women seen at the Frauenklinik at University Hospital Basel

Exclusion Criteria:

• pregnant women with already known hemoglobinopathy

• refusal of participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Frauenklinik University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Irene Hoesli, Prof. Dr., Frauenklinik Universitätsspital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04029142
• Other Study ID Numbers: 2019-01065; sp19Amstad
• First Posted: Jul 23, 2019
• Last Update Posted: Oct 14, 2021
• Last Verified: Oct 1, 2021

• 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: Hemoglobinopathies

Study Results

No Results Posted as of Oct 14, 2021