Clinical Trial: Use of Warfarin After the First Trimester in Pregnant Women With APS

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

Official Title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome

Brief Summary: Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)

Detailed Summary: Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.
Sponsor: Mohamed Sayed Abdelhafez

Current Primary Outcome: Fetal loss [ Time Frame: From 12 weeks to 42 weeks gestational age ]

Unexplained fetal death of morphologically normal fetus after the first trimester


Original Primary Outcome: Fetal loss [ Time Frame: 12 months ]

Unexplained fetal death of morphologically normal fetus after the first trimester


Current Secondary Outcome:

  • 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:

  • Preterm delivery [ Time Frame: 12 months ]
    Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
  • Intrauterine growth restriction (IUGR) [ Time Frame: 12 months ]
    Birth weight less than the 10th percentile for gestational age
  • Congenital fetal malformations [ Time Frame: 12 months ]


Information By: Mansoura University

Dates:
Date Received: November 25, 2014
Date Started: November 2014
Date Completion: March 2018
Last Updated: May 8, 2017
Last Verified: May 2017