NCT04029142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,785

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

July 17, 2019

Last Update Submit

February 29, 2024

Conditions

Hemoglobinopathies

Keywords

thalassemiasickle cell anaemiamolecular genetic analysis

Outcome Measures

Primary Outcomes (1)

  • identification of hemoglobinopathies

    identification of hemoglobinopathies by investigating routine lab samples

    single time point assessment at baseline

Interventions

Review of routine lab dataDIAGNOSTIC_TEST

Review of routine lab data from pregnant women (first trimester)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women seen at the Frauenklinik at University Hospital Basel

You may qualify if:

  • pregnant women seen at the Frauenklinik at University Hospital Basel

You may not qualify if:

  • pregnant women with already known hemoglobinopathy
  • refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frauenklinik University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 32699163RESULT

MeSH Terms

Conditions

HemoglobinopathiesThalassemiaAnemia, Sickle Cell

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemia

Study Officials

  • Irene Hoesli, Prof. Dr.

    Frauenklinik Universitätsspital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 23, 2019

Study Start

July 3, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations

CH(1)