Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy

Phase 3

Completed

• Conditions: Placental Insufficiency; High Risk Pregnant Women; Preeclampsia
• Interventions: Drug: Enoxaparin

• Registration Number: NCT01388322
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-07-04
• Study First Posted: 2011-07-06
• Study Start: 2012-03
• Primary Completion: 2016-06
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 361

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Enoxaparin	Subcutaneous administration of one dose daily of enoxaparin

Primary Outcome Measures

Name	Time	Method
Development of any of these complications of placental insufficiency	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 Outcome Measures

Name	Time	Method
Neonatal Data	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
Days of hospitalization during pregnancy	from randomization to the time of delivery (30 weeks)	Days of hospitalization during pregnancy
Gestational age at birth	from date of randomization until the date of delivery (assessed up to 30 weeks)	Gestational age at birth
Days of maternal hospitalization in the postpartum period	from delivery until discharge (an expected average of one week)	Days of maternal hospitalization in the postpartum period

Trial Locations

Locations (4)

Hospital de Cruces; 🇪🇸 Barakaldo, Vizcaya, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Sant Joan de Deu; 🇪🇸 Esplugues de Llobregat, Barcelona, Spain

Parc sanitari Sant Joan de Deu; 🇪🇸 Sant Boi de Llobregat, Barcelona, Spain