Screening for Hemoglobinopathies in Pregnant Women | NCT04029142

Studies
Screening for Hemoglobinopathies in Pregnant Women

NCT04029142

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Mar 4, 2024Actual

Enrollment

1,785Actual

Phase

Not provided

Conditions

Hemoglobinopathies

Interventions

Review of routine lab data

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2019Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Jul 17, 2019

First Submission Date that Met QC Criteria

Jul 22, 2019

First Posted Date

Jul 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 29, 2024

Last Update Posted Date

Mar 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,785Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Review of routine lab data	Diagnostic Test	Review of routine lab data from pregnant women (first trimester)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
identification of hemoglobinopathies	identification of hemoglobinopathies by investigating routine lab samples	single time point assessment at baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

pregnant women seen at the Frauenklinik at University Hospital Basel

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irene Hoesli, Prof. Dr.	Frauenklinik Universitätsspital Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frauenklinik University Hospital Basel		Basel		4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32699163	Result	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.

ID	Term
D006453	Hemoglobinopathies
D013789	Thalassemia
D000755	Anemia, Sickle Cell

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities