Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy

NCT01388322 | Completed Phase 3

• 2 other identifiers: HOPPE-Trial2010-023597-39
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 4

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.

Conditions

High Risk Pregnant Women; Placental Insufficiency; Preeclampsia

Keywords

Pregnancy; Preeclampsia; Placental insufficiency

Outcome Measures

Primary Outcomes (1)

• Development of any of these complications of placental insufficiency

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

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

Secondary Outcomes (4)

• Gestational age at birth

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

• Days of hospitalization during pregnancy

  from randomization to the time of delivery (30 weeks)

• Days of maternal hospitalization in the postpartum period

  from delivery until discharge (an expected average of one week)

• Neonatal Data

  after the delivery (an expected average of one month)

Study Arms (2)

Enoxaparin

EXPERIMENTAL

Subcutaneous administration of one dose daily of enoxaparin

Drug: Enoxaparin

expectant management

NO INTERVENTION

Usual management

Interventions

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.

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Hospital Vall d'Hebron: collaborator
• Hospital Sant Joan de Deu: collaborator
• Hospital de Cruces: collaborator
• Parc Sanitari Sant Joan de Déu: collaborator

Study Sites (4)

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Parc sanitari Sant Joan de Deu

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

MeSH Terms

Conditions

Placental Insufficiency; Pre-Eclampsia

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Lluís Cabero, MD PhD

  Hospital Vall d'Hebron

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 6, 2011
• Study Start: March 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

ES (4)