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

King's College London
5th Floor Thomas Guy House
Guy's Campus
London
SE1 9RT
United Kingdom

Phone +44 (0)20 7188 0192
Email theresa.marteau@kcl.ac.uk

Study information

Study designPartial factorial cluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymSHIFT (Screening for Haemoglobinopathies In the First Trimester)
Study objectivesOffering 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) studiedSickle cell and thalassaemia
InterventionPlease 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 typeOther
Primary outcome measure1. 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 measures1. Rates of informed choice about undergoing the screening test
2. Time in pregnancy when women know the carrier status of the baby’s father
3. Couples emotional responses to carrier testing after they have received their test result
Overall study start date01/10/2004
Completion date30/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants990 women and 330 partners
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2004
Date of final enrolment30/04/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College London
London
SE1 9RT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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