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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02838030
Other study ID # ECAALA
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date August 2021

Study information

Verified date November 2020
Source University of Guadalajara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 82
Est. completion date August 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
L-arginine
3 gr per day
Placebo (for L-arginine)
3 gr per day
acetylsalicylic acid
3 gr per day

Locations

Country Name City State
Mexico Antiguo Hospital Civil Fray Antonio Alcalde Guadalajara Jalisco

Sponsors (5)

Lead Sponsor Collaborator
University of Guadalajara MD Diego Hernández Molina, PhD Ernesto Javier Ramírez Lizardo, PhD Fernando Grover Páez, PhD Sylvia Elena Totsuka Sutto

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of preeclampsia from 20 weeks gestation until 37 weeks
Primary severity of preeclampsia from 20 weeks gestation until 37 weeks
Secondary Pulmonary edema maternal at week 37
Secondary Acute myocardial infarction maternal at week 37
Secondary Stroke maternal at week 37
Secondary Acute respiratory distress syndrome maternal at week 37
Secondary Coagulopathy maternal at week 37
Secondary Renal failure maternal at week 37
Secondary Retinal damage maternal at week 37
Secondary maternal mortality at week 37
Secondary Birth weight birth
Secondary Intrauterine growth restriction birth
Secondary Fetal mortality birth
Secondary systolic blood pressure maternal from 12 weeks gestation until 37 weeks
Secondary diastolic blood pressure maternal from 12 weeks gestation until 37 weeks
Secondary Mean blood pressure maternal from 12 weeks gestation until 37 weeks
Secondary Pulse wave velocity maternal from 12 weeks gestation until 37 weeks
Secondary Adverse effects maternal from 12 weeks gestation until 37 weeks
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