Efficacy and Safety of L Arginine to Prevent Preeclampsia

Study Overview
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Brief Summary
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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 Description
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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

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Dietary Supplement: L arginine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (A)<br>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<br>* calcined magnesia<br>|
| Experimental: L arginine (B)<br>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<br>* L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of L arginine to prevent preeclampsia | 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 | from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perinatal outcome | 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 | from time to delivery until two weeks after, approximalety 18 weeks | 
| safety of L arginine | 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) | from time of randomization until birth approximalety 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L arginine, Preeclampsia