Clinical trial NCT01388322: Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: High Risk Pregnant Women
Placental Insufficiency
Preeclampsia
Keywords: Pregnancy
Preeclampsia
Placental insufficiency
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Hospital Sant Joan de Deu
name: Hospital de Cruces
name: Parc Sanitari Sant Joan de Déu
First posted: 2011-07-06
Enrollment: 361
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Development of any of these complications of placental insufficiency
timeFrame: from date of randomization until the date of delivery (assessed up to 30 weeks)
Secondary outcomes:
measure: Gestational age at birth
timeFrame: from date of randomization until the date of delivery (assessed up to 30 weeks)
measure: Days of hospitalization during pregnancy
timeFrame: from randomization to the time of delivery (30 weeks)
measure: Days of maternal hospitalization in the postpartum period
timeFrame: from delivery until discharge (an expected average of one week)
measure: Neonatal Data
timeFrame: after the delivery (an expected average of one month)
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Sant Boi de Llobregat
country: Spain
facility: Parc sanitari Sant Joan de Deu
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Lluís Cabero, MD PhD
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron
name: Elisa Llurba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Sant Joan de Deu
name: Maria Dolores Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Cruces
name: Txantón Martínez-Astorquiza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parc Sanitari Sant Joan de Deu
name: Raul De Diego, M.D.
role: PRINCIPAL_INVESTIGATOR
References: