Pilot study of a randomised controlled trial of antenatal thromboprophylaxis
ISRCTN | ISRCTN21644138 |
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DOI | https://doi.org/10.1186/ISRCTN21644138 |
Secondary identifying numbers | N/A |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 17/02/2010
- 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 Peter Brocklehurst
Scientific
Scientific
National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
Oxford
OX3 7LF
United Kingdom
Phone | +44 (0)1865 227000 |
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peter.brocklehurst@perinat.ox.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Scientific title | |
Study acronym | APPLE |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Pregnancy and childbirth: thromboembolic disease (TED) |
Intervention | Heparin vs placebo |
Intervention type | Other |
Primary outcome measure | Incidence of thromboembolic disease and side effects (especially osteoporosis) will be recorded |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/08/1999 |
Completion date | 01/02/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 16 |
Key inclusion criteria | Pregnant women who are at risk of developing thromboembolic disease (TED) |
Key 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 |
Date of first enrolment | 01/08/1999 |
Date of final enrolment | 01/02/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
National Perinatal Epidemiology Unit
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/10/2004 | Yes | No |