Pilot study of a randomised controlled trial of antenatal thromboprophylaxis

ISRCTN	ISRCTN21644138
DOI	https://doi.org/10.1186/ISRCTN21644138
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
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

Participant type(s)	Patient
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

National Perinatal Epidemiology Unit

Oxford
OX3 7LF
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive South East (UK)

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2004		Yes	No