Overview

Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

Status:
Suspended
Trial end date:
2021-08-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Guadalajara
Collaborators:
MD Diego Hernández Molina
PhD Ernesto Javier Ramírez Lizardo
PhD Fernando Grover Páez
PhD Sylvia Elena Totsuka Sutto
Treatments:
Aspirin
Criteria
Inclusion Criteria:

- Pregnant before 12 weeks of gestation

- High risk of preeclampsia

- Signature of informed consent in writing

Exclusion Criteria:

- Noncompliance > 20% of drug intake

- Lack of tolerability L-arginine or acetylsalicylic acid

- Compliance with at least one non-inclusion criteria during the course of the study

- Serious adverse event

- Withdrawal of consent