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Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

Primary Purpose

High Risk Pregnancy

Status
Suspended
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
L-arginine
Placebo (for L-arginine)
acetylsalicylic acid
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Risk Pregnancy focused on measuring Preeclampsia, L-arginine

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Antiguo Hospital Civil Fray Antonio Alcalde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

acetylsalicylic acid and L-arginine

acetylsalicylic acid and placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Incidence of preeclampsia
severity of preeclampsia

Secondary Outcome Measures

Pulmonary edema maternal
Acute myocardial infarction maternal
Stroke maternal
Acute respiratory distress syndrome maternal
Coagulopathy maternal
Renal failure maternal
Retinal damage maternal
maternal mortality
Birth weight
Intrauterine growth restriction
Fetal mortality
systolic blood pressure maternal
diastolic blood pressure maternal
Mean blood pressure maternal
Pulse wave velocity maternal
Adverse effects maternal

Full Information

First Posted
May 26, 2016
Last Updated
November 25, 2020
Sponsor
University of Guadalajara
Collaborators
PhD Ernesto Javier Ramírez Lizardo, PhD Sylvia Elena Totsuka Sutto, PhD Fernando Grover Páez, MD Diego Hernández Molina
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1. Study Identification

Unique Protocol Identification Number
NCT02838030
Brief Title
Efficacy of Aspirin and L-arginine in High Risk Preeclamptic
Official Title
Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Suspended
Why Stopped
COVID-19 pandemic
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
Collaborators
PhD Ernesto Javier Ramírez Lizardo, PhD Sylvia Elena Totsuka Sutto, PhD Fernando Grover Páez, MD Diego Hernández Molina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Pregnancy
Keywords
Preeclampsia, L-arginine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acetylsalicylic acid and L-arginine
Arm Type
Experimental
Arm 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
Arm Title
acetylsalicylic acid and placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
L-arginine
Other Intervention Name(s)
arginine
Intervention Description
3 gr per day
Intervention Type
Drug
Intervention Name(s)
Placebo (for L-arginine)
Other Intervention Name(s)
Magnesia calcined
Intervention Description
3 gr per day
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
Other Intervention Name(s)
aspirin
Intervention Description
3 gr per day
Primary Outcome Measure Information:
Title
Incidence of preeclampsia
Time Frame
from 20 weeks gestation until 37 weeks
Title
severity of preeclampsia
Time Frame
from 20 weeks gestation until 37 weeks
Secondary Outcome Measure Information:
Title
Pulmonary edema maternal
Time Frame
at week 37
Title
Acute myocardial infarction maternal
Time Frame
at week 37
Title
Stroke maternal
Time Frame
at week 37
Title
Acute respiratory distress syndrome maternal
Time Frame
at week 37
Title
Coagulopathy maternal
Time Frame
at week 37
Title
Renal failure maternal
Time Frame
at week 37
Title
Retinal damage maternal
Time Frame
at week 37
Title
maternal mortality
Time Frame
at week 37
Title
Birth weight
Time Frame
birth
Title
Intrauterine growth restriction
Time Frame
birth
Title
Fetal mortality
Time Frame
birth
Title
systolic blood pressure maternal
Time Frame
from 12 weeks gestation until 37 weeks
Title
diastolic blood pressure maternal
Time Frame
from 12 weeks gestation until 37 weeks
Title
Mean blood pressure maternal
Time Frame
from 12 weeks gestation until 37 weeks
Title
Pulse wave velocity maternal
Time Frame
from 12 weeks gestation until 37 weeks
Title
Adverse effects maternal
Time Frame
from 12 weeks gestation until 37 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonel García Benavides, PhD
Organizational Affiliation
University Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antiguo Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

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