Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

High Risk Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02838030
• Other study ID #: ECAALA
• Status: Suspended
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• High Risk Pregnancy
• Pre-Eclampsia

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