Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

University of Guadalajara

Status and phase: Suspended; Phase 2

Conditions: High Risk Pregnancy

Treatments: Drug: Placebo (for L-arginine); Drug: acetylsalicylic acid; Drug: L-arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT02838030

ECAALA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

acetylsalicylic acid and L-arginine

Experimental group

Description:

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

Treatment:

Drug: L-arginine

Drug: acetylsalicylic acid

acetylsalicylic acid and placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: acetylsalicylic acid

Drug: Placebo (for L-arginine)