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Pre- and neonatal screening of hemoglobinopathies: a prospective study.


- candidate number1954
- NTR NumberNTR622
- ISRCTNISRCTN88941850
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR31-jan-2006
- Secondary IDs05-83 MEC
- Public TitlePre- and neonatal screening of hemoglobinopathies: a prospective study.
- Scientific TitlePre- and neonatal screening of hemoglobinopathies: a prospective study.
- ACRONYMScreening of hemoglobinopathies
- hypothesisThe carrier frequence of hemoglobinopathies is > 0,05 and screening for primary prevention is cost-effective.
- Healt Condition(s) or Problem(s) studiedHemoglobinopathies
- Inclusion criteria1. Pregnant females before the 16th week of pregancy and newborns.
2. Informed consent.
- Exclusion criteriaKnown hemoglobinopathy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate28-feb-2007
- Target number of participants2000
- InterventionsUnselected group of pregnant females (n = 1000) and a group of newborns (n = 1000) will be screened for hemoglobinopathies.
- Primary outcomeCarrier frequence of hemoglobinopathies.
- Secondary outcome1. Serum ferritin;
2. Compliance to prenatal testing;
3. Cost-Effectiveness.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESM.D. J.L.H. Kerkhoffs
- CONTACT for SCIENTIFIC QUERIESM.D. J.L.H. Kerkhoffs
- Sponsor/Initiator Haga Teaching Hospital, Department of Pulmonology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsP.C. Giordano et al. A confidential inquiry estimating the number of patients affected with sickle cell disease and thalassemia major confirms the need for a preventive strategy in the Netherlands. hemoglobin (2004),28: 287-296

Disorders of hemoglobin. Genetics, pathophysiology and clinical managment. Edit by Steinberg et al. Cambridge Univ. Press 2001
- Brief summaryIn a period of 2 years an unselected group of pregnant females (n = 1000) and a group of newborns (n = 1000) will be screened for hemoglobinopathies. Primary endpoint is the carrier frequence of hemoglobinopathies, secondary endpoints are the compliance to prenatal testing, iron stores and cost-effectiveness.
- Main changes (audit trail)
- RECORD31-jan-2006 - 16-nov-2009


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