Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

Summary

Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality. Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far there is no effective treatment to decrease the morbidity and mortality of this entity, so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition to the information the investigators have reduced the effect of these strategies on arterial stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this population. It is for this that is of interest to know the efficacy and safety of the combination of L-arginine low dose, which is known as an important eNOS in NO production substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the prevention of preeclampsia and also determine their effect on arterial stiffness as a noninvasive method, as is the applanation tonometry.

Conditions

• High Risk Pregnancy

Interventions

DRUG

L-arginine

3 gr per day

DRUG

Placebo (for L-arginine)

3 gr per day

DRUG

acetylsalicylic acid

3 gr per day

Sponsors & Collaborators

• PhD Ernesto Javier Ramírez Lizardo

  collaborator UNKNOWN

• PhD Sylvia Elena Totsuka Sutto

  collaborator UNKNOWN

• PhD Fernando Grover Páez

  collaborator UNKNOWN

• MD Diego Hernández Molina

  collaborator UNKNOWN

• University of Guadalajara

  lead OTHER

Principal Investigators

• Leonel García Benavides, PhD · University Guadalajara

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2021-07-31

Completion

2021-08-31

Countries

• Mexico

Study Locations