A Phase 4 interventional study of L-arginine 3g + L-Citruline 2 g and Placebo in Fetal Growth Retardation, sponsored by Hospital Civil de Guadalajara. Status unknown. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Hospital Civil de Guadalajara · Phase 4, Interventional, and Treatment
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.
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's planned enrollment of 41 is below the median of 101 across 117 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Hospital Civil de Guadalajara is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: L-arginine 3g and L-citruline 2g, Food supplement, PO , for 24 h, until birth
Dietary Supplement: L-arginine 3g + L-Citruline 2 g
Placebo 3g ( starch ) PO for 24 h. until birth
Drug: Placebo
receive L-arginine 3g + l-Citruline 2 g PO, for 24 h, until birth.
Also known as: L-arginine 3g, L-Citruline 2 g
receive placebo 3g PO, for 24 h, until birth.
Fetal Growth
fetal weight gain
Time frame: 10 weeks
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Hospital Civil de Guadalajara