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
Protocol serial number	HTA 03/02/03
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Primary study design	Interventional
Study design	Partial factorial cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	1320
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

United Kingdom
England

Study participating centre

King's College London

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes