Clinical Trial: Efficacy and Safety of L Arginine to Prevent Preeclampsia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies

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


Detailed Summary:

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


Sponsor: Hospital Civil Juan I. Menchaca

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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)


Original Secondary Outcome: Same as current

Information By: Hospital Civil Juan I. Menchaca

Dates:
Date Received: January 27, 2015
Date Started: August 2010
Date Completion:
Last Updated: March 3, 2016
Last Verified: March 2016