Contact information
Type
Scientific
Primary contact
Dr Peter Brocklehurst
ORCID ID
Contact details
National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 227000
peter.brocklehurst@perinat.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
APPLE
Study hypothesis
In many hospitals, pregnant women who are at risk of developing thromboembolic disease (TED) are given thromboprophylaxis using heparin, despite the fact that there is no good quality evidence from randomized control trials (RCT) that this therapy is effective. Moreover, heparin can cause serious side effects, especially osteoporosis. The risks of side effects are unknown, and it is possible that thromboprophylaxis may cause more harm then good. RCTs are necessary to evaluate without bias the risks and benefits of this therapy.
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 and childbirth: thromboembolic disease (TED)
Intervention
Heparin vs placebo
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of thromboembolic disease and side effects (especially osteoporosis) will be recorded
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/1999
Overall trial end date
01/02/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women who are at risk of developing thromboembolic disease (TED)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
16
Participant exclusion criteria
1. Women are known to have a thrombophillia sensitivity
2. Have had more than one previous episode of TED
3. Are known to have heparin sensitivity
4. Have had a previous cerebral venous thrombosis
5. Are receiving long term anticoagulant therapy
Recruitment start date
01/08/1999
Recruitment end date
01/02/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
National Perinatal Epidemiology Unit
Oxford
OX3 7LF
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 South East (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
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15507957
Publication citations
-
Results
Gates S, Brocklehurst P, Ayers S, Bowler U, , Thromboprophylaxis and pregnancy: two randomized controlled pilot trials that used low-molecular-weight heparin., Am. J. Obstet. Gynecol., 2004, 191, 4, 1296-1303, doi: 10.1016/j.ajog.2004.03.039.