CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
enoxaparin 40mg plus low dose aspirin +1 moredrug
Likely dose
enoxaparin 40mg plus low dose aspirinfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01051778
NCT01051778Phase 2Completed
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Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial

Cairo University·interventional·Posted Jan 20, 2010·Updated Aug 29, 2011

In Brief

A Phase 2 clinical trial evaluating enoxaparin 40mg plus low dose aspirin and Heparin calcium5,000 U twice daily plus low dose aspirin for Recurrent Abortion. Completed, enrolled 60 participants across 2 sites.

Detailed Summary

The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Abortion
CountriesEgypt
CollaboratorsAhmed Elgazzar Hospital

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 20, 2010
Enrollment StartJun 1, 2006
Primary CompletionNov 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.4 years ago

Interventions

enoxaparin 40mg plus low dose aspirindrug

Enoxaparin 40mg/day by subcutaneous injection ( Clexane 40 mg, Aventis international, Sanofi-aventis France ) is started when the serum pregnancy test become positive. Enoxaparin is stopped 2 days before planned induction of labor or cesarean section and twice-daily unfractionated heparin (UFH) is initiated. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop enoxaparin or UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID)) is started before conception and continued until 36 weeks gestation.

Heparin calcium5,000 U twice daily plus low dose aspirindrug

Heparin Calcium 5,000 U twice daily (Cal-Heparine, Amoun Pharmaceutical Co, Egypt) by subcutaneous injection is started when the serum pregnancy test become positive. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID))is started before conception and continued until 36 weeks gestation .