A Phase 2 interventional study of L-arginine and Placebo (for L-arginine) in High Risk Pregnancy, sponsored by University of Guadalajara. Suspended at 1 site in Mexico. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2020-11-27.
Sponsored by University of Guadalajara · Phase 2, Interventional, and Prevention
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.
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.
883 studies on the registry are indexed under Pre-Eclampsia; 238 are open to participants now.
This study's planned enrollment of 82 is below the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Guadalajara is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: 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
Drug: Placebo (for L-arginine) · Drug: acetylsalicylic acid
3 gr per day
Also known as: arginine
3 gr per day
Also known as: Magnesia calcined
3 gr per day
Also known as: aspirin
Incidence of preeclampsia
Time frame: from 20 weeks gestation until 37 weeks
severity of preeclampsia
Time frame: from 20 weeks gestation until 37 weeks
Pulmonary edema maternal
Time frame: at week 37
Acute myocardial infarction maternal
Time frame: at week 37
Stroke maternal
Time frame: at week 37
Acute respiratory distress syndrome maternal
Time frame: at week 37
Coagulopathy maternal
Time frame: at week 37
Renal failure maternal
Time frame: at week 37
Retinal damage maternal
Time frame: at week 37
maternal mortality
Time frame: at week 37
Birth weight
Time frame: birth
Intrauterine growth restriction
Time frame: birth
Fetal mortality
Time frame: birth
systolic blood pressure maternal
Time frame: from 12 weeks gestation until 37 weeks
diastolic blood pressure maternal
Time frame: from 12 weeks gestation until 37 weeks
Mean blood pressure maternal
Time frame: from 12 weeks gestation until 37 weeks
Pulse wave velocity maternal
Time frame: from 12 weeks gestation until 37 weeks
Adverse effects maternal
Time frame: from 12 weeks gestation until 37 weeks
Plan to share: No
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This study is suspended, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Guadalajara