Clinical Trial: Low Weight Heparin prOphylaxis for Placental‐Mediated Complications of PrEgnancy

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

Official Title: Enoxaparin for the Prevention of Placental‐Mediated Complications of Pregnancy in Women With Obstetric History or Abnormal Uterine Artery Doppler at First Trimester Ultrasound and Without Thromb

Brief Summary: 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.

Detailed Summary:
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: Development of any of these complications of placental insufficiency [ Time Frame: from date of randomization until the date of delivery (assessed up to 30 weeks) ]

Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gestational age at birth [ Time Frame: from date of randomization until the date of delivery (assessed up to 30 weeks) ]
    Gestational age at birth
  • Days of hospitalization during pregnancy [ Time Frame: from randomization to the time of delivery (30 weeks) ]
    Days of hospitalization during pregnancy
  • Days of maternal hospitalization in the postpartum period [ Time Frame: from delivery until discharge (an expected average of one week) ]
    Days of maternal hospitalization in the postpartum period
  • Neonatal Data [ Time Frame: after the delivery (an expected average of one month) ]
    weight, height, head circumference, Apgar score 1‐5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: June 28, 2011
Date Started: March 2012
Date Completion:
Last Updated: December 20, 2016
Last Verified: December 2016