Contact information
Type
Scientific
Primary contact
Dr Roy Farquharson
ORCID ID
Contact details
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 708 9988
Roy.Farquharson@lwh-tr.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHC18084
Study information
Scientific title
Acronym
Study hypothesis
To 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Pregnancy; antiphospholipid antibody syndrome
Intervention
1. Aspirin
2. Aspirin and low molecular weight heparin
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Live birth rate in both arms of the trial (defined as the live birth rate after 24 weeks gestation).
Secondary outcome measures
The 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 trial start date
01/01/1998
Overall trial end date
01/01/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Pregnant women with antiphospholipid antibody syndrome
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
98 (added 12/01/10; see publication)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1998
Recruitment end date
01/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive North West (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
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12220757
Publication citations
-
Results
Farquharson RG, Quenby S, Greaves M, Antiphospholipid syndrome in pregnancy: a randomized, controlled trial of treatment., Obstet Gynecol, 2002, 100, 3, 408-413.