Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes