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Completed

NCT Number: NCT02363348

Efficacy and Safety of L Arginine to Prevent Preeclampsia

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

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Panduro Baron J Guadalupe

Guadalajara, Jalisco, 44340, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

L arginine

Dietary Supplement

L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.

Placebo

Other

calcined magnesia

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital Civil Juan I. Menchaca

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Feb 16, 2015
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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