Phase 2
N=60
Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome
Recurrent Abortion
Bottom Line
View on ClinicalTrials.gov: NCT01051778 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) — 24; 20 Percentage of pregnancies
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- enoxaparin 40mg plus low dose aspirin (Drug); Heparin calcium5,000 U twice daily plus low dose aspirin (Drug)
- Age
- Adult · 19+ yrs
- Sex
- Female
- Sponsor
- Cairo University
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) |
24; 20 | — |
| SECONDARY Minor and Major Bleeding |
— | — |
| SECONDARY Thrombocytopenia |
— | — |
| SECONDARY Preeclampsia |
— | — |
| SECONDARY IUFD |
— | — |
| SECONDARY Preterm Delivery |
— | — |
| SECONDARY Spontaneous Osteoporotic Fractures |
— | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patients with a minimum of three consecutive pregnancy losses before 10 weeks gestation
- Positive lupus anticoagulant and/or anticardiolipin antibodies (IgG and IgM) on at least two occasions twelve weeks apart .
- Age between 19 - 37 years,
- Body mass index between 19-30
Exclusion Criteria
- Parental chromosomal abnormalities
- Uterine abnormalities
- Luteal phase defect
- Systemic lupus erythematosus
- Previous thromboembolism
- Sensitivity to aspirin.
Data sourced from ClinicalTrials.gov (NCT01051778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.