NCT01388322

Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy

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 Thrombophilia: a Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 361 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Risk Pregnant Women
• Placental Insufficiency
• Preeclampsia

Interventions

Type	Name	Description
DRUG	Enoxaparin	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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2011-07-06
• Last updated: 2016-12-21

Locations

4 sites across 1 country: Spain