Condition category
Haematological Disorders
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
02/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.L.H. Kerkhoffs

ORCID ID

Contact details

HagaHospital
Leyweg 275
The Hague
2545 CH
Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

METC-nr 05-83; NTR622

Study information

Scientific title

Acronym

Study hypothesis

The carrier frequence of haemoglobinopathies is greater than 0.05 and screening for primary prevention is cost-effective.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Cross sectional study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Haemoglobinopathies

Intervention

Unselected group of pregnant females (n = 1000) and a group of newborns (n = 1000) will be screened for haemoglobinopathies.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Carrier frequence of haemoglobinopathies.

Secondary outcome measures

1. Serum ferritin
2. Compliance to prenatal testing
3. Cost-effectiveness

Overall trial start date

01/03/2006

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant females before the 16th week of pregnancy and newborns
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2000

Participant exclusion criteria

Known haemoglobinopathy

Recruitment start date

01/03/2006

Recruitment end date

28/02/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

HagaHospital
The Hague
2545 CH
Netherlands

Sponsor information

Organisation

HagaZiekenhuis (The Netherlands)

Sponsor details

Leyweg 275
The Hague
2545 CH
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes