Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180778
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 13, 2005
September 13, 2005
October 2005
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Successful pregnancy outcome
Same as current
No Changes Posted
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Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss
Randomised Controlled Trial of Low Dose Steroid +Aspirin +Heparin Versus Aspirin+Heparin Amongst Pregnant Women With APS

Does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?

Over the last decade, the APS has emerged as most important treatable cause of recurrent miscarriages. The pathogenesis of fetal loss in this condition is still remains obscure. Despite the success of aspirin + heparin treatment, some pregnant women with APS repeatedly miscarry even on treatment. The trial is designed to determine if addition of steroids has an success in these women. This is in view of recent in vitro data from our unit reporting that there is an increase decidual cytokine response in APS positive women.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Antiphospholipid Syndrome
Drug: Low dose steroids
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
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Inclusion Criteria:

History of 3 or more consecutive miscarriages and positive antiphospholipid antibodies on at least two occasions more than 6 weeks apart before becoming pregnant and an unsuccessful pregnancy with aspirin + heparin with a karyotype of miscarriage either unavailable or normal (46XX/ 46XY).

Exclusion Criteria:

Abnormal karyotype of women or partner, previous thromboembolism, SLE, diabetes mellitus, hypertension, sensitivity to aspirin, heparin and prednisolone, multiple pregnancy.

Female
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No
Contact: Lesley Regan, FRCOG 02078861050 l.regan@imperial.ac.uk
United Kingdom
 
NCT00180778
05/Q0403/155, 2005-004182-42
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Imperial College London
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Principal Investigator: Raj Rai, MRCOG Imperial College London
Imperial College London
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP