Low Weight Heparin prOphylaxis for Placental‐Mediated Complications of PrEgnancy

Preeclampsia Clinical Trial

— HOPPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388322
• Other study ID #: HOPPE-Trial
• Secondary ID: 2010-023597-39
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2011
• Last updated: December 20, 2016
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• High Risk Pregnant Women
• Placental Insufficiency
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de Cruces	Barakaldo	Vizcaya
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat	Barcelona
Spain	Parc sanitari Sant Joan de Deu	Sant Boi de Llobregat	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Hospital de Cruces, Hospital Sant Joan de Deu, Hospital Vall d'Hebron, Parc Sanitari Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from date of randomization until the date of delivery (assessed up to 30 weeks)	No
Secondary	Gestational age at birth	Gestational age at birth	from date of randomization until the date of delivery (assessed up to 30 weeks)	No
Secondary	Days of hospitalization during pregnancy	Days of hospitalization during pregnancy	from randomization to the time of delivery (30 weeks)	No
Secondary	Days of maternal hospitalization in the postpartum period	Days of maternal hospitalization in the postpartum period	from delivery until discharge (an expected average of one week)	No
Secondary	Neonatal Data	weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications	after the delivery (an expected average of one month)	No