Condition category
Haematological Disorders
Date applied
30/04/2004
Date assigned
30/04/2004
Last edited
31/01/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 baby’s 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

http://www.dh.gov.uk/en/index.htm

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

  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