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Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

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ClinicalTrials.gov Identifier: NCT02838030
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
PhD Ernesto Javier Ramírez Lizardo
PhD Sylvia Elena Totsuka Sutto
PhD Fernando Grover Páez
MD Diego Hernández Molina
Information provided by (Responsible Party):
Leonel Garcia Benavides, 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.

Condition or disease Intervention/treatment Phase
High Risk Pregnancy Drug: L-arginine Drug: Placebo (for L-arginine) Drug: acetylsalicylic acid 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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 Name: arginine

Drug: acetylsalicylic acid
3 gr per day
Other Name: aspirin

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 Name: Magnesia calcined

Drug: acetylsalicylic acid
3 gr per day
Other Name: aspirin




Primary Outcome Measures :
  1. Incidence of preeclampsia [ Time Frame: from 20 weeks gestation until 37 weeks ]
  2. severity of preeclampsia [ Time Frame: from 20 weeks gestation until 37 weeks ]

Secondary Outcome Measures :
  1. Pulmonary edema maternal [ Time Frame: at week 37 ]
  2. Acute myocardial infarction maternal [ Time Frame: at week 37 ]
  3. Stroke maternal [ Time Frame: at week 37 ]
  4. Acute respiratory distress syndrome maternal [ Time Frame: at week 37 ]
  5. Coagulopathy maternal [ Time Frame: at week 37 ]
  6. Renal failure maternal [ Time Frame: at week 37 ]
  7. Retinal damage maternal [ Time Frame: at week 37 ]
  8. maternal mortality [ Time Frame: at week 37 ]
  9. Birth weight [ Time Frame: birth ]
  10. Intrauterine growth restriction [ Time Frame: birth ]
  11. Fetal mortality [ Time Frame: birth ]
  12. systolic blood pressure maternal [ Time Frame: from 12 weeks gestation until 37 weeks ]
  13. diastolic blood pressure maternal [ Time Frame: from 12 weeks gestation until 37 weeks ]
  14. Mean blood pressure maternal [ Time Frame: from 12 weeks gestation until 37 weeks ]
  15. Pulse wave velocity maternal [ Time Frame: from 12 weeks gestation until 37 weeks ]
  16. Adverse effects maternal [ Time Frame: from 12 weeks gestation until 37 weeks ]


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838030


Contacts
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Contact: Leonel García Benavides, PhD 10585200 drleonelgb@hotmail.com

Locations
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Mexico
Antiguo Hospital Civil Fray Antonio Alcalde Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Francisco Javier Hernandez Mora, Obstetrician    3331700456    frank.gine@gmail.com   
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
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Principal Investigator: Leonel García Benavides, PhD University Guadalajara

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Responsible Party: Leonel Garcia Benavides, PhD, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02838030     History of Changes
Other Study ID Numbers: ECAALA
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leonel Garcia Benavides, University of Guadalajara:
Preeclampsia
L-arginine

Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics