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NCT00180778 Clinical Trial

Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss

Antiphospholipid Syndrome Clinical Trial

Official title:
Randomised Controlled Trial of Low Dose Steroid +Aspirin +Heparin Versus Aspirin+Heparin Amongst Pregnant Women With APS

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00180778
Other study ID # 05/Q0403/155
Secondary ID 2005-004182-42
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date October 2005
Est. completion date October 2005

Study information
Verified date February 2024
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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?

Description:

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Low dose steroids

Locations
Country Name City State
United Kingdom St. Mary's Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful pregnancy outcome
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