Clinical Trial: Timing of Initiation of LMWH Administration in Pregnant Women With APS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome

Brief Summary: Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)

Detailed Summary: Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy
Sponsor: Mohamed Sayed Abdelhafez

Current Primary Outcome: Ongoing pregnancy rate [ Time Frame: After 12 weeks gestational age ]

Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fetal loss [ Time Frame: From 20 weeks to 42 weeks gestational age ]
    Unexplained fetal death of morphologically normal fetus after the first trimester
  • Preterm delivery [ Time Frame: From 20 weeks to 34 weeks gestational age ]
    Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
  • Intrauterine growth restriction (IUGR) [ Time Frame: At birth ]
    Birth weight less than the 10th percentile for gestational age
  • Congenital fetal malformations [ Time Frame: At birth ]


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: December 22, 2014
Date Started: December 2014
Date Completion: March 2017
Last Updated: November 23, 2016
Last Verified: November 2016