Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy

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

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.

Sponsors & Collaborators

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Sant Joan de Deu

  collaborator OTHER

• Hospital de Cruces

  collaborator OTHER

• Parc Sanitari Sant Joan de Déu

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Lluís Cabero, MD PhD · Hospital Vall d'Hebron

• Elisa Llurba, MD · Hospital Vall d'Hebron

• Maria Dolores Gómez, MD · Hospital Sant Joan de Deu

• Txantón Martínez-Astorquiza, MD · Hospital de Cruces

• Raul De Diego, M.D. · Parc Sanitari Sant Joan de Deu

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2016-06-30

Completion

2016-12-31

Countries

• Spain

Study Locations