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Efficacy and Safety of L Arginine to Prevent Preeclampsia

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ClinicalTrials.gov Identifier: NCT02363348
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Eva Elizabet Camarena Pulido, Hospital Civil Juan I. Menchaca

Brief Summary:

Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia.

applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes


Condition or disease Intervention/treatment Phase
Preeclampsia Dietary Supplement: L arginine Other: Placebo Phase 3

Detailed Description:

Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo.

Each three weeks were evaluated in search of high blood pressure and proteinuria.

The follow-up was until the end of pregnancy and two weeks after this

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo (A)

were administered 5 capsules per day each capsule contained 600 mg of magnesia calcinada. Duration: from week 20th of pregnancy until the end of the same.

dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner.

Other: Placebo
calcined magnesia

Experimental: L arginine (B)
were administered 5 capsules per day each capsule contained 600 mg of L arginine. Duration: from week 20th of pregnancy until the end of the same dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner.
Dietary Supplement: L arginine
L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.




Primary Outcome Measures :
  1. efficacy of L arginine to prevent preeclampsia [ Time Frame: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks. ]
    number of patients with diagnosis of preeclampsia. the diagnostic was performed when they presented arterial blood pressure above 140/90 mm / Hg in the span of 6 hours and accompanied by proteinuria (>300 milligrams in one sample) number of patients with high blood pression and proteinuria (ACOG criteria) The evaluations were performed every three weeks until week 31, then every two weeks until week 35 and weekly until pregnancy ended


Secondary Outcome Measures :
  1. perinatal outcome [ Time Frame: from time to delivery until two weeks after, approximalety 18 weeks ]
    number of patients with adverse perinatal outcome: APGAR scale < 7 at five minutes, low weight for gestational age (< 10 percentile) and CAPURRO scale < 37 weeks also the need to enter the neonatal intensive care unit

  2. safety of L arginine [ Time Frame: from time of randomization until birth approximalety 18 weeks ]
    number of patients with adverse reactions and/or any alteration of blood test. participants are awarded a diary which recorded the symptoms that caused them any discomfort. If the discomfort was important it was reported via telephone with the treating physician. the paper was reviewed at each appointment. Blood tests such as blood count, liver function tests and kidney were performed every three weeks in search of alterations in the parameters considered normal by those tests (ACOG criteria)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)

Exclusion Criteria:

  • pregnant women carriers of chronic renal failure
  • pre gestational diabetes
  • multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)

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): NCT02363348


Locations
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Mexico
Panduro Baron J Guadalupe
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Hospital Civil Juan I. Menchaca
Investigators
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Study Chair: Guadalupe Panduro, Ph Hospital Civil Juan I. Menchaca
Publications of Results:
Other Publications:
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Responsible Party: Eva Elizabet Camarena Pulido, MD, Hospital Civil Juan I. Menchaca
ClinicalTrials.gov Identifier: NCT02363348    
Other Study ID Numbers: SSJ1054-11
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Eva Elizabet Camarena Pulido, Hospital Civil Juan I. Menchaca:
L arginine
Preeclampsia
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications