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Clinical Trial Summary

Introduction: The high incidence of intrauterine growth restriction is a public health problem; in this pathology, newborns present weight below the 10th percentile, this implies an increase in morbidity in the short term (complications due to hypoxia) and long term (pathologies typical of Fetal Programming) as well as the cost of health services. L-arginine at different doses has been used for some pathologies such as preeclampsia with controversial results. Authors have mentioned that the joint administration of l-citrulline can increase the efficacy of l-arginine. A stunted fetus is a challenge for the fetal physician; due to the complexity of the follow-up, but above all to determine the moment for the termination of the pregnancy. Finding some treatment to promote weight gain would improve the short- and long-term expectations of these infants. General objective To determine the efficacy of L-arginine + L-Citrulline (3 / 2g) every 24 hours, in fetuses with a decrease in their growth curve in the third trimester of pregnancy. Material and methods Clinical trial, parallel, controlled, randomized simple, Double blind. Two groups of pregnant women will be carried out in the third trimester; fetus with a decrease in its growth curve, percentile> 10 and <25 for gestation age, they will be given an informed consent letter and they will be randomized (double blind), they will proceed to give intervention (L-arginine + Citrin (3 / 2 g) every 24 hours Vs placebo), a follow-up will be carried out every two weeks, where the weight and growth curve will be calculated in percentile, until the resolution of the pregnancy and data will be taken from the perinatal results in both groups. Statistic analysis Medics of central tendency will be calculated and Chi squared will be applied for qualitative variables, T of student for qualitative variables and it is considered P <0.005.

Clinical Trial Description

50 patients with a pregnancy of more than 26 weeks of gestation, 25 with intervention and 25 control will be included; in which the fetus is between 10 and 25th percentile . It will be carried out in the obstetric service of the old civil hospital, with a double-blind randomization. Evaluations will be carried out every two weeks where the fetal weight, umbilical artery Doppler, middle cerebral artery, venous duct, uterine arteries, amniotic fluid, placenta will be evaluated. The assessment will be made until birth, from where the birth weight, height, Apgar, Capurro score, characteristics and placental weight, approximate bleeding will be collected. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05029778
Study type Interventional
Source Hospital Civil de Guadalajara
Contact Jorge Bravo Rubio, Dr
Phone 3221186759
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date October 20, 2021
Completion date January 20, 2024

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