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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)
Women will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGPrivate practice settings
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGFetal loss
Unexplained fetal death of morphologically normal fetus after the first trimester
Time frame: From 12 weeks to 42 weeks gestational age
Preterm delivery
Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
Time frame: From 20 weeks to 34 weeks gestational age
Intrauterine growth restriction (IUGR)
Birth weight less than the 10th percentile for gestational age
Time frame: At birth
Congenital fetal malformations
Congenital fetal malformations
Time frame: At birth
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