Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk

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.

Study Overview

• Status: Suspended
• Conditions: High Risk Pregnancy
• Intervention / Treatment: Drug: L-arginine; Drug: acetylsalicylic acid; Drug: Placebo (for L-arginine)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Antiguo Hospital Civil Fray Antonio Alcalde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acetylsalicylic acid and L-arginine; acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and L-arginine 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination	Drug: L-arginine; 3 gr per day; Other Names: arginine; Drug: acetylsalicylic acid; 3 gr per day; Other Names: aspirin
Placebo Comparator: acetylsalicylic acid and placebo; acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and placebo 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination	Drug: acetylsalicylic acid; 3 gr per day; Other Names: aspirin; Drug: Placebo (for L-arginine); 3 gr per day; Other Names: Magnesia calcined

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of preeclampsia	from 20 weeks gestation until 37 weeks
severity of preeclampsia	from 20 weeks gestation until 37 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pulmonary edema maternal	at week 37
Acute myocardial infarction maternal	at week 37
Stroke maternal	at week 37
Acute respiratory distress syndrome maternal	at week 37
Coagulopathy maternal	at week 37
Renal failure maternal	at week 37
Retinal damage maternal	at week 37
maternal mortality	at week 37
Birth weight	birth
Intrauterine growth restriction	birth
Fetal mortality	birth
systolic blood pressure maternal	from 12 weeks gestation until 37 weeks
diastolic blood pressure maternal	from 12 weeks gestation until 37 weeks
Mean blood pressure maternal	from 12 weeks gestation until 37 weeks
Pulse wave velocity maternal	from 12 weeks gestation until 37 weeks
Adverse effects maternal	from 12 weeks gestation until 37 weeks

Collaborators and Investigators

• Sponsor: University of Guadalajara
• Collaborators: PhD Ernesto Javier Ramírez Lizardo; PhD Sylvia Elena Totsuka Sutto; PhD Fernando Grover Páez; MD Diego Hernández Molina
• Investigators: Principal Investigator: Leonel García Benavides, PhD, University Guadalajara

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: L-arginine; Preeclampsia
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: ECAALA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No