Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy (HOPPE)

Vall d'Hebron University Hospital (HUVH)

Status and phase

Completed

Phase 3

Conditions

Preeclampsia

High Risk Pregnant Women

Placental Insufficiency

Treatments

Drug: Enoxaparin

Study type

Interventional

Funder types

Other

Identifiers

NCT01388322

2010-023597-39 (EudraCT Number)

HOPPE-Trial

Details and patient eligibility

About

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.

Enrollment

361 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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