Prenatal and neonatal screening of haemoglobinopathies: a prospective study
| ISRCTN | ISRCTN88941850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88941850 |
| Secondary identifying numbers | METC-nr 05-83; NTR622 |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 02/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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
Contact information
Dr J.L.H. Kerkhoffs
Scientific
Scientific
HagaHospital
Leyweg 275
The Hague
2545 CH
Netherlands
| Phone | +31 (0)70 3592004 |
|---|---|
| J.Kerkhoffs@hagaziekenhuis.nl |
Study information
| Study design | Cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Not specified |
| Study type | Screening |
| 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 | Carrier frequence of haemoglobinopathies. |
| Secondary outcome measures | 1. Serum ferritin 2. Compliance to prenatal testing 3. Cost-effectiveness |
| Overall study start date | 01/03/2006 |
| Completion date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
HagaHospital
The Hague
2545 CH
Netherlands
2545 CH
Netherlands
Sponsor information
HagaZiekenhuis (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Leyweg 275
The Hague
2545 CH
Netherlands
"ROR" |
https://ror.org/03q4p1y48 |
|---|
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
