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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 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: November 10, 2014
Last verified: November 2014

June 28, 2011
November 10, 2014
March 2012
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01388322 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Low Weight Heparin prOphylaxis for Placental‐Mediated Complications of PrEgnancy
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • High Risk Pregnant Women
  • Placental Insufficiency
  • Preeclampsia
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.
  • Experimental: Enoxaparin
    Subcutaneous administration of one dose daily of enoxaparin
    Intervention: Drug: Enoxaparin
  • No Intervention: expectant management
    Usual management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
361
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Elisa Llurba, MD 34934893085 elluba@vhebron.net
Contact: Inmaculada Fuentes, MD 0034934894113 ext 4881 inma.fuentes@vhir.org
Spain
 
NCT01388322
HOPPE‐Trial, 2010‐023597‐39
No
Hospital Universitari Vall d'Hebron Research Institute
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
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
Hospital Universitari Vall d'Hebron Research Institute
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP