Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss

Imperial College London

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Antiphospholipid Syndrome

Treatments

Drug: Low dose steroids

Study type

Interventional

Funder types

Other

Identifiers

NCT00180778

05/Q0403/155

2005-004182-42

Details and patient eligibility

About

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?

Full 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.

Sex

Female

Volunteers

No Healthy Volunteers

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.