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Completed

NCT Number: NCT01388322

Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy

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.

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Key information

Conditions

High Risk Pregnant Women Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Placenta Diseases Placental Insufficiency Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Vall d'Hebron, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. Gestational age at birth

    Time frame: from date of randomization until the date of delivery (assessed up to 30 weeks)

    Gestational age at birth

  2. Days of hospitalization during pregnancy

    Time frame: from randomization to the time of delivery (30 weeks)

    Days of hospitalization during pregnancy

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Hospital Sant Joan de Deu
  • Hospital Vall d'Hebron
  • Hospital de Cruces
  • Parc Sanitari Sant Joan de Déu

Registry information

Official study 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

Acronym: HOPPE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2011
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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