Efficacy of Aspirin and L-arginine in High Risk Preeclamptic
- Conditions
- High Risk Pregnancy
- Interventions
- Registration Number
- NCT02838030
- Lead Sponsor
- University of Guadalajara
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 82
- Pregnant before 12 weeks of gestation
- High risk of preeclampsia
- Signature of informed consent in writing
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description acetylsalicylic acid and placebo Placebo (for L-arginine) 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 acetylsalicylic acid and L-arginine 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 acetylsalicylic acid and L-arginine acetylsalicylic acid 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 acetylsalicylic acid and placebo acetylsalicylic acid 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
- Primary Outcome Measures
Name Time Method Incidence of preeclampsia from 20 weeks gestation until 37 weeks severity of preeclampsia from 20 weeks gestation until 37 weeks
- Secondary Outcome Measures
Name Time Method Intrauterine growth restriction birth Acute myocardial infarction maternal at week 37 Mean blood pressure maternal from 12 weeks gestation until 37 weeks Pulse wave velocity maternal from 12 weeks gestation until 37 weeks Pulmonary edema maternal at week 37 Coagulopathy maternal at week 37 Stroke maternal at week 37 Acute respiratory distress syndrome maternal at week 37 maternal mortality at week 37 Birth weight birth systolic blood pressure maternal from 12 weeks gestation until 37 weeks diastolic blood pressure maternal from 12 weeks gestation until 37 weeks Renal failure maternal at week 37 Adverse effects maternal from 12 weeks gestation until 37 weeks Retinal damage maternal at week 37 Fetal mortality birth
Trial Locations
- Locations (1)
Antiguo Hospital Civil Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico