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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Hospital Sant Joan de Deu
Hospital de Cruces
Parc Sanitari Sant Joan de Déu
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01388322
First received: June 28, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
High Risk Pregnant Women
Placental Insufficiency
Preeclampsia
Drug: Enoxaparin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise


Secondary Outcome Measures:
  • Gestational age at birth [ Time Frame: from date of randomization until the date of delivery (assessed up to 30 weeks) ] [ Designated as safety issue: No ]
    Gestational age at birth

  • Days of hospitalization during pregnancy [ Time Frame: from randomization to the time of delivery (30 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Days of maternal hospitalization in the postpartum period

  • Neonatal Data [ Time Frame: after the delivery (an expected average of one month) ] [ Designated as safety issue: No ]
    weight, height, head circumference, Apgar score 1‐5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications


Estimated Enrollment: 361
Study Start Date: March 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enoxaparin
Subcutaneous administration of one dose daily of enoxaparin
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.
No Intervention: expectant management
Usual management

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388322

Contacts
Contact: Elisa Llurba, MD 34934893085 elluba@vhebron.net
Contact: Inmaculada Fuentes, MD 0034934894113 ext 4881 inma.fuentes@vhir.org

Locations
Spain
Hospital Sant Joan de Deu Not yet recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Contact: Maria Dolores Gómez, MD         
Principal Investigator: Maria Dolores Gómez, MD         
Parc sanitari Sant Joan de Deu Not yet recruiting
Sant Boi de Llobregat, Barcelona, Spain, 08830
Contact: Raul De Diego, M.D.         
Principal Investigator: Raul De Diego, M.D.         
Hospital de Cruces Recruiting
Barakaldo, Vizcaya, Spain, 48903
Contact: Txantón Martínez-Astorquiza, MD         
Principal Investigator: Txantón Martínez-Astorquiza, MD         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Elisa Llurba, MD    0034934893085    ellurba@vhebron.net   
Contact: Inmaculada Fuentes, MD    0034934894113 ext 4881    inma.fuentes@vhir.org   
Principal Investigator: Elisa Llurba, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Hospital Vall d'Hebron
Hospital Sant Joan de Deu
Hospital de Cruces
Parc Sanitari Sant Joan de Déu
Investigators
Study Chair: Lluís Cabero, MD PhD Hospital Vall d'Hebron
Principal Investigator: Elisa Llurba, MD Hospital Vall d'Hebron
Principal Investigator: Maria Dolores Gómez, MD Hospital Sant Joan de Deu
Principal Investigator: Txantón Martínez-Astorquiza, MD Hospital de Cruces
Principal Investigator: Raul De Diego, M.D. Parc Sanitari Sant Joan de Deu
  More Information

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01388322     History of Changes
Other Study ID Numbers: HOPPE‐Trial, 2010‐023597‐39
Study First Received: June 28, 2011
Last Updated: March 31, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Pregnancy
Preeclampsia
Placental insufficiency

Additional relevant MeSH terms:
Placental Insufficiency
Pre-Eclampsia
Pregnancy Complications
Placenta Diseases
Hypertension, Pregnancy-Induced
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014