Prenatal and neonatal screening of haemoglobinopathies: a prospective study

ISRCTN	ISRCTN88941850
DOI	https://doi.org/10.1186/ISRCTN88941850
Protocol serial number	METC-nr 05-83; NTR622
Sponsor	HagaZiekenhuis (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr J.L.H. Kerkhoffs
Scientific

HagaHospital
Leyweg 275
The Hague
2545 CH
Netherlands

Phone	+31 (0)70 3592004
Email	J.Kerkhoffs@hagaziekenhuis.nl

Primary study design	Observational
Study design	Cross sectional study
Secondary study design	Cross-section survey
Scientific title
Study objectives	The carrier frequence of haemoglobinopathies is greater than 0.05 and screening for primary prevention is cost-effective.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Haemoglobinopathies
Intervention	Unselected group of pregnant females (n = 1000) and a group of newborns (n = 1000) will be screened for haemoglobinopathies.
Intervention type	Other
Primary outcome measure(s)	Carrier frequence of haemoglobinopathies.
Key secondary outcome measure(s)	1. Serum ferritin 2. Compliance to prenatal testing 3. Cost-effectiveness
Completion date	28/02/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	2000
Key inclusion criteria	1. Pregnant females before the 16th week of pregnancy and newborns 2. Informed consent
Key exclusion criteria	Known haemoglobinopathy
Date of first enrolment	01/03/2006
Date of final enrolment	28/02/2007

HagaHospital

The Hague
2545 CH
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan