Antiphospholipid syndrome in pregnancy: A controlled treatment trial

ISRCTN ISRCTN55179279
DOI https://doi.org/10.1186/ISRCTN55179279
Secondary identifying numbers RHC18084
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
12/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Roy Farquharson
Scientific

Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone +44 (0)151 708 9988
Email Roy.Farquharson@lwh-tr.nwest.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study objectivesTo assess the efficacy of low dose heparin in the treatment of antiphospholipid antibody syndrome during pregnancy, comparing low dose aspirin with low dose aspirin combined with low molecular weight heparin, in women suffering from recurring pregnancy loss.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy; antiphospholipid antibody syndrome
Intervention1. Aspirin
2. Aspirin and low molecular weight heparin
Intervention typeOther
Primary outcome measureLive birth rate in both arms of the trial (defined as the live birth rate after 24 weeks gestation).
Secondary outcome measuresThe secondary outcome measures will concern maternal morbidity, e.g. osteoporosis, and fetal parameters, such as premature delivery and the incidence for "small for dates".
Overall study start date01/01/1998
Completion date01/01/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants98 (added 12/01/10; see publication)
Key inclusion criteriaPregnant women with antiphospholipid antibody syndrome
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/01/1998
Date of final enrolment01/01/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive North West (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 01/09/2002 Yes No