Clinical Trial: Low Molecular Weight Heparin in Recurrent Miscarriage With Negative Antiphospholipid Antibodies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Low Molecular Weight Heparin for Treatment of Recurrent Miscarriage With Negative Antiphospholipid Antibodies: a Randomized Controlled Trial

Brief Summary:

Recurrent miscarriage (RM) is traditionally defined as three or more consecutive miscarriages occurring before 20 weeks post-menstruation. It is one of the most common clinical problems in reproduction, yet a definite cause can be established in only 50 percent of cases (ACOG practice bulletin, 2002). Many etiological factors have been proposed but none of them has been fully substantiated. RM has been directly associated with maternal thrombophilic disorders, parental chromosomal anomalies, and structural uterine anomalies and indirectly with maternal immune dysfunction and endocrine abnormalities.

The association between pregnancy loss and antiphospholipid antibodies (aPL) was first noticed in the latter third of the last century. The antiphospholipid syndrome (APS) is characterized by the presence of antiphospholipid antibodies (APLA), associated with venous and/or arterial thrombosis, and/or pregnancy loss. The adverse pregnancy outcomes associated with the presence of APLAs include: recurrent fetal loss, intrauterine growth restriction (IUGR), and severe pre-eclampsia especially of early onset.

Testing the effect of Heparin in treatment of cases with RA but negative for APA has bee done in few animal and clinical studies. Animal studies showed that the subset of cases with disorders suspicious for APS but who had negative test results for LAC and aCL is carrying antibodies pathogenic to murine pregnancy. Testing other immunoglobulin G may provide additional means to identify cases with an yet uncharacterized immune condition. Moreover, the clinical relevance of low levels of APLA in these women remains unproved.

Randomized prospective study was done to assess the efficacy of early thromboprophylaxis of Low molecular weight heparin (LMWH) (Enoxaparin sodium 20 mg, once

Detailed Summary:
Sponsor: Omar Mamdouh Shaaban

Current Primary Outcome: Continuation of viable pregnancy beyond 20 weeks gestation [ Time Frame: 20 weeks gestation ]

Number of patients who will continue with a viable pregnancy beyond 20 weeks gestation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fetal viability at the end of the 34th week of pregnancy. [ Time Frame: 34 weeks gestation ]
  • Normal fetal anatomy by ultrasound scan [ Time Frame: 20 weeks gestation ]
  • Side effect encountered from treatment [ Time Frame: 20 weeks gestation ]


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: May 26, 2012
Date Started: January 2010
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017