Low Weight Heparin prOphylaxis for Placental‐Mediated Complications of PrEgnancy

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Enoxaparin
    • Subcutaneous administration of one dose daily of enoxaparin
  • No Intervention: expectant management
    • Usual management

Clinical Trial Outcome Measures

Primary 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)
    • Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise

Secondary Measures

  • Gestational age at birth
    • Time Frame: from date of randomization until the date of delivery (assessed up to 30 weeks)
    • Gestational age at birth
  • Days of hospitalization during pregnancy
    • Time Frame: from randomization to the time of delivery (30 weeks)
    • 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)
    • Days of maternal hospitalization in the postpartum period
  • Neonatal Data
    • Time Frame: after the delivery (an expected average of one month)
    • weight, height, head circumference, Apgar score 1‐5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari Vall d’Hebron Research Institute
  • Collaborator
    • Hospital Vall d’Hebron
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lluís Cabero, MD PhD, Study Chair, Hospital Vall d’Hebron
    • Elisa Llurba, MD, Principal Investigator, Hospital Vall d’Hebron
    • Maria Dolores Gómez, MD, Principal Investigator, Hospital Sant Joan de Deu
    • Txantón Martínez-Astorquiza, MD, Principal Investigator, Hospital de Cruces
    • Raul De Diego, M.D., Principal Investigator, Parc Sanitari Sant Joan de Deu

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