Contact information
Type
Scientific
Primary contact
Prof Theresa Marteau
ORCID ID
Contact details
King's College London
5th Floor Thomas Guy House
Guy's Campus
London
SE1 9RT
United Kingdom
+44 (0)20 7188 0192
theresa.marteau@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 03/02/03
Study information
Scientific title
Acronym
SHIFT (Screening for Haemoglobinopathies In the First Trimester)
Study hypothesis
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
Ethics approval received from the local medical ethics committee on the 23rd March 2005 (ref: 05/Q0501/36)
Study design
Partial factorial cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2004
Overall trial end date
30/04/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
990 women and 330 partners
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
30/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
1. 2010 results published by funding body in http://www.ncbi.nlm.nih.gov/pubmed/20416236
2. 2010 results published by the BMJ in http://www.ncbi.nlm.nih.gov/pubmed/20923841
3. 2011 results published by Journal of Medical Screening in http://www.ncbi.nlm.nih.gov/pubmed/21852698
Publication citations
-
Results published by funding body
Dormandy E, Bryan S, Gulliford MC, Roberts TE, Ades AE, Calnan M, Atkin K, Karnon J, Barton PM, Logan J, Kavalier F, Harris HJ, Johnston TA, Anionwu EN, Davis V, Brown K, Juarez-Garcia A, Tsianakas V, Marteau TM, Antenatal screening for haemoglobinopathies in primary care: a cohort study and cluster randomised trial to inform a simulation model. The Screening for Haemoglobinopathies in First Trimester (SHIFT) trial., Health Technol Assess, 2010, 14, 20, 1-160, doi: 10.3310/hta14200.
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Results published by the BMJ
Dormandy E, Gulliford M, Bryan S, Roberts TE, Calnan M, Atkin K, Karnon J, Logan J, Kavalier F, Harris HJ, Johnston TA, Anionwu EN, Tsianakas V, Jones P, Marteau TM, Effectiveness of earlier antenatal screening for sickle cell disease and thalassaemia in primary care: cluster randomised trial., BMJ, 2010, 341, c5132.
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Results published by Journal of Medical Screening
Brown K, Dormandy E, Reid E, Gulliford M, Marteau T, Impact on informed choice of offering antenatal sickle cell and thalassaemia screening in primary care: a randomized trial., J Med Screen, 2011, 18, 2, 65-75, doi: 10.1258/jms.2011.010132.