Antenatal screening for haemoglobinopathies in primary care: a cluster randomised trial to inform a simulation model
| ISRCTN | ISRCTN00677850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00677850 |
| Secondary identifying numbers | HTA 03/02/03 |
- Submission date
- 30/04/2004
- Registration date
- 30/04/2004
- Last edited
- 31/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Theresa Marteau
Scientific
Scientific
King's College London
5th Floor Thomas Guy House
Guy's Campus
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 0192 |
|---|---|
| theresa.marteau@kcl.ac.uk |
Study information
| Study design | Partial factorial cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | SHIFT (Screening for Haemoglobinopathies In the First Trimester) |
| Study objectives | Offering antenatal screening for sickle cell and thalassaemia when women first report their pregnancy as opposed to offering it as part of community based secondary care increases the proportion of women who know their carrier status before ten weeks gestation. Protocol can be found at: http://www.ncchta.org/protocols/200300020003.pdf More information can be found at: http://www.hta.ac.uk/1401 |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee on the 23rd March 2005 (ref: 05/Q0501/36) |
| Health condition(s) or problem(s) studied | Sickle cell and thalassaemia |
| Intervention | Please note that the anticipated end date of this trial has been extended to 30 April 2008 as of 14 December 2007 (Anticipated end date provided at time of registration: 30 September 2007). Closed to recruitment of participants: follow-up continuing. A partial factorial cluster randomised controlled trial with general practice as the unit of randomisation. Participating general practices will be randomised to offering screening in one of three ways: Group 1: In primary care, when women first report their pregnancies with parallel partner testing (i.e. partners of all women are offered screening at the same time as the pregnant women) Group 2: In primary care, when women first report their pregnancies with sequential partner testing; (i.e. partners of women are only offered screening if the pregnant woman is found to be a carrier) Group 3: In community-based secondary care, when women are booked by midwives with sequential partner testing |
| Intervention type | Other |
| Primary outcome measure | 1. Time in pregnancy of offer of carrier screening for sickle cell and thalassaemia 2. Time in pregnancy of testing for carrier status for sickle cell and thalassaemia |
| Secondary outcome measures | 1. Rates of informed choice about undergoing the screening test 2. Time in pregnancy when women know the carrier status of the babys father 3. Couples emotional responses to carrier testing after they have received their test result |
| Overall study start date | 01/10/2004 |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 990 women and 330 partners |
| Key inclusion criteria | 1. Eligible pregnant women receiving antenatal care at participating general practices 2. Aged 18 and over 3. Wanting to continue with the pregnancy 4. Carrier status is not documented in primary care records |
| Key exclusion criteria | 1. Women who do not want to continue with the pregnancies 2. Women who are more than 18 weeks gestation when reporting their pregnancies |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results published by funding body | 01/04/2010 | Yes | No | |
| Results article | results published by the BMJ | 05/10/2010 | Yes | No | |
| Results article | results published by Journal of Medical Screening | 01/10/2011 | Yes | No |
