Pilot study of a randomised controlled trial of antenatal thromboprophylaxis

ISRCTN ISRCTN21644138
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

National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
Oxford
OX3 7LF
United Kingdom

Phone +44 (0)1865 227000
Email peter.brocklehurst@perinat.ox.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study acronymAPPLE
Study objectivesIn 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) studiedPregnancy and childbirth: thromboembolic disease (TED)
InterventionHeparin vs placebo
Intervention typeOther
Primary outcome measureIncidence of thromboembolic disease and side effects (especially osteoporosis) will be recorded
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/1999
Completion date01/02/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants16
Key inclusion criteriaPregnant women who are at risk of developing thromboembolic disease (TED)
Key exclusion criteria1. 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 enrolment01/08/1999
Date of final enrolment01/02/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

National Perinatal Epidemiology Unit
Oxford
OX3 7LF
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 South East (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 01/10/2004 Yes No