Condition category
Haematological Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Theresa Marteau


Contact details

King's College London
5th Floor Thomas Guy House
Guy's Campus
United Kingdom
+44 (0)20 7188 0192

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 03/02/03

Study information

Scientific title


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:
More information can be found at:

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


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Sickle cell and thalassaemia


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



Not Specified

Drug names

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 baby’s father
3. Couples emotional responses to carrier testing after they have received their test result

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

King's College London
United Kingdom

Sponsor information


Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2010 results published by funding body in
2. 2010 results published by the BMJ in
3. 2011 results published by Journal of Medical Screening in

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes