Pilot study of a randomised controlled trial of antenatal thromboprophylaxis

ISRCTN	ISRCTN21644138
DOI	https://doi.org/10.1186/ISRCTN21644138
Protocol serial number	N/A
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Incidence of thromboembolic disease and side effects (especially osteoporosis) will be recorded
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2002

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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