This is a Multicenter, randomized, open-label, parallel groups study to test the hypothesis that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks of gestation could improve maternal and perinatal outcome in women at high risk for developing placental-mediated pregnancy complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
361
40 mg (4000 IU) women \<80 kg at the time of randomization or 60 mg (6000 IU) women\> 80 kg at the time of randomization One dose daily. Subcutaneous administration. Treatment periods: the same day of the Initiation visit (from 9 to 13.6 weeks of gestation) until 36 weeks gestation.
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Parc sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Development of any of these complications of placental insufficiency
Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise
Time frame: from date of randomization until the date of delivery (assessed up to 30 weeks)
Gestational age at birth
Gestational age at birth
Time frame: from date of randomization until the date of delivery (assessed up to 30 weeks)
Days of hospitalization during pregnancy
Days of hospitalization during pregnancy
Time frame: from randomization to the time of delivery (30 weeks)
Days of maternal hospitalization in the postpartum period
Days of maternal hospitalization in the postpartum period
Time frame: from delivery until discharge (an expected average of one week)
Neonatal Data
weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications
Time frame: after the delivery (an expected average of one month)
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