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Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss

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ClinicalTrials.gov Identifier: NCT00180778
Recruitment Status : Unknown
Verified September 2005 by Imperial College London.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Information provided by:

September 13, 2005
September 16, 2005
September 16, 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.
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Unknown status
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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.

Sexes Eligible for Study: Female
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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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