This trial is active, not recruiting.

Conditions high risk pregnant women, placental insufficiency, preeclampsia
Treatment enoxaparin
Phase phase 3
Sponsor Hospital Universitari Vall d'Hebron Research Institute
Collaborator Hospital Vall d'Hebron
Start date March 2012
End date June 2016
Trial size 361 participants
Trial identifier NCT01388322, 2010‐023597‐39, HOPPE‐Trial


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Subcutaneous administration of one dose daily of 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.
(No Intervention)
Usual management

Primary Outcomes

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)

Secondary Outcomes

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
time frame: from randomization to the time of delivery (30 weeks)
Days of maternal hospitalization in the postpartum period
time frame: from delivery until discharge (an expected average of one week)
Neonatal Data
time frame: after the delivery (an expected average of one month)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Pregnant women ≥18 years - Gestational age < 14 weeks at randomisation - One or more of the following complications in a previous pregnancy: - Severe PE resulting in delivery before 32 weeks of gestation - Newborn weight less than the 10th percentile and documented abnormal Doppler in the umbilical artery during pregnancy before 32 weeks gestation - Abruption of placenta - Unexplained intrauterine death between 20‐41,6 weeks of gestation secondary of placental insufficiency or - Uterine arteries Pulsatility Index (mPI) Doppler ≥95th percentile at 11‐14 weeks of gestation. Exclusion Criteria: - Multiple pregnancy - Abnormal thrombophilia study - Alcohol or illicit drug use - Severe fetal malformations or chromosomal abnormalities - Previous history of infertility ( 3 or more early miscarriages) - Maternal HIV, Cytomegalovirus or toxoplasma infection - Known fetal abnormality or chromosomal defect at randomisation - Women with previous venous or arterial thrombotic event - Organic lesions that could increase the hemorrhagic risk: gastric ulcus, stroke, a recent hemorrhagic event, high risk situations for hemorrhagic event - Known allergy to heparin or LMWH, thrombopenia or thrombosis episode due to heparin treatment - Contraindication to LMWH - An absolute indication for anticoagulant therapy: venous deep thrombosis, pulmonary embolism, ovaric hyperestimulation, cardiophaty, others - Metabolic disorders a risk for development of PE and/or IUGR: Type I diabetes, hipertiroidism, chronic renal insufficiency

Additional Information

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 Thrombophilia: a Multicenter Randomized Controlled Trial
Principal investigator Elisa Llurba, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute.