Clinical trial NCT02838030: Efficacy of Aspirin and L-arginine in High Risk Preeclamptic
Official title: Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: High Risk Pregnancy
Keywords: Preeclampsia
L-arginine
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: PhD Ernesto Javier Ramírez Lizardo
name: PhD Sylvia Elena Totsuka Sutto
name: PhD Fernando Grover Páez
name: MD Diego Hernández Molina
First posted: 2016-07-20
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: It will conduct a clinical trial, double-blind, randomized and placebo control group female patients with 12 weeks of gestation have one or more risk factors for developing preeclampsia. 2 groups will be formed with 82 patients each, chance will determine the intervention (acetylsalicylic + L-arginine acetylsalicylic acid or acid + placebo). At the beginning and end of the intervention clinical and laboratory determinations, the end will be determined in both groups the incidence of preeclampsia, severity and number needed to treat is made. The data obtained were analyzed using SPSS statistical software version 22. It was considered statistically significant at p \<0.05.

Eligibility 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

Primary outcomes:
measure: Incidence of preeclampsia
timeFrame: from 20 weeks gestation until 37 weeks
measure: severity of preeclampsia
timeFrame: from 20 weeks gestation until 37 weeks
Secondary outcomes:
measure: Pulmonary edema maternal
timeFrame: at week 37
measure: Acute myocardial infarction maternal
timeFrame: at week 37
measure: Stroke maternal
timeFrame: at week 37
measure: Acute respiratory distress syndrome maternal
timeFrame: at week 37
measure: Coagulopathy maternal
timeFrame: at week 37
measure: Renal failure maternal
timeFrame: at week 37
measure: Retinal damage maternal
timeFrame: at week 37
measure: maternal mortality
timeFrame: at week 37
measure: Birth weight
timeFrame: birth
measure: Intrauterine growth restriction
timeFrame: birth
measure: Fetal mortality
timeFrame: birth
measure: systolic blood pressure maternal
timeFrame: from 12 weeks gestation until 37 weeks
measure: diastolic blood pressure maternal
timeFrame: from 12 weeks gestation until 37 weeks
measure: Mean blood pressure maternal
timeFrame: from 12 weeks gestation until 37 weeks
measure: Pulse wave velocity maternal
timeFrame: from 12 weeks gestation until 37 weeks
measure: Adverse effects maternal
timeFrame: from 12 weeks gestation until 37 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: University Guadalajara
name: Leonel García Benavides, PhD
role: PRINCIPAL_INVESTIGATOR
References: