Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively 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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12220757

Publication citations

  1. Results

    Farquharson RG, Quenby S, Greaves M, Antiphospholipid syndrome in pregnancy: a randomized, controlled trial of treatment., Obstet Gynecol, 2002, 100, 3, 408-413.

Additional files

Editorial Notes