Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy
NCT ID: NCT01388322
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
361 participants
INTERVENTIONAL
2012-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Enoxaparin
Subcutaneous administration of one dose daily of enoxaparin
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.
expectant management
Usual management
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Hospital Vall d'Hebron
OTHER
Hospital Sant Joan de Deu
OTHER
Hospital de Cruces
OTHER
Parc Sanitari Sant Joan de Déu
OTHER
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Lluís Cabero, MD PhD
Role: STUDY_CHAIR
Hospital Vall d'Hebron
Elisa Llurba, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Vall d'Hebron
Maria Dolores Gómez, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sant Joan de Deu
Txantón Martínez-Astorquiza, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Cruces
Raul De Diego, M.D.
Role: PRINCIPAL_INVESTIGATOR
Parc Sanitari Sant Joan de Deu
Locations
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Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Parc sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Countries
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Other Identifiers
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2010-023597-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HOPPE-Trial
Identifier Type: -
Identifier Source: org_study_id