Efficacy of Aspirin and L-arginine in High Risk Preeclamptic
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: acetylsalicylic acid and 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 |
Drug: L-arginine
3 gr per day
Other Names:
Drug: acetylsalicylic acid
3 gr per day
Other Names:
|
| Placebo Comparator: acetylsalicylic acid and placebo 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)
3 gr per day
Other Names:
Drug: acetylsalicylic acid
3 gr per day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of preeclampsia [from 20 weeks gestation until 37 weeks]
- severity of preeclampsia [from 20 weeks gestation until 37 weeks]
Secondary Outcome Measures
- Pulmonary edema maternal [at week 37]
- Acute myocardial infarction maternal [at week 37]
- Stroke maternal [at week 37]
- Acute respiratory distress syndrome maternal [at week 37]
- Coagulopathy maternal [at week 37]
- Renal failure maternal [at week 37]
- Retinal damage maternal [at week 37]
- maternal mortality [at week 37]
- Birth weight [birth]
- Intrauterine growth restriction [birth]
- Fetal mortality [birth]
- systolic blood pressure maternal [from 12 weeks gestation until 37 weeks]
- diastolic blood pressure maternal [from 12 weeks gestation until 37 weeks]
- Mean blood pressure maternal [from 12 weeks gestation until 37 weeks]
- Pulse wave velocity maternal [from 12 weeks gestation until 37 weeks]
- Adverse effects maternal [from 12 weeks gestation until 37 weeks]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Antiguo Hospital Civil Fray Antonio Alcalde | Guadalajara | Jalisco | Mexico | 44280 |
Sponsors and Collaborators
- University of Guadalajara
- PhD Ernesto Javier Ramírez Lizardo
- PhD Sylvia Elena Totsuka Sutto
- PhD Fernando Grover Páez
- MD Diego Hernández Molina
Investigators
- Principal Investigator: Leonel García Benavides, PhD, University Guadalajara
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECAALA