L-Arginine treatment for severe vascular fetal intrauterine growth restriction: a randomized double-bind controlled trial.
OBJECTIVE
Infants born with severe IUGR are exposed to higher neonatal mortality and morbidity rates, as compared with appropriate-for-gestational-age. They are exposed to a higher risk of developing chronic disease such as hypertension, coronary artery disease, obesity, and type 2 diabetes in adulthood. L-Arginine is a precursor of nitric oxide (NO) and may play a role in placental vascular mediation or local vasodilatation.


OBJECTIVE
The current study was designed to determine whether oral supplementation of gravid patients suffering from severe intrauterine growth restriction (IUGR) with L-arginine, would enhance birth weight and/or decrease neonatal morbidity.


METHODS
Forty-four patients with a singleton pregnancy who had been referred for IUGR detected by ultrasonic examination were included. Vascular IUGR was defined by fetal abdominal circumference less than or equal to the 3rd percentile, associated with abnormal uterine Doppler. After double-blind randomization, patients received either 14 g/day of L-arginine, or a placebo.


RESULTS
The characteristics of the two groups of patients (IUGR with L-arginine vs IUGR with placebo) were similar upon randomization. There was no significant difference between the two groups concerning birth weight (1042+/-476 vs. 1068+/-452 g). At delivery, maternal and neonatal characteristics were similar in the two groups. There was no difference in the Clinical Risk Index for Babies (CRIB) score, the duration of ventilatory assistance, nor the delay between birth and full enteral feeding between the two groups.


CONCLUSIONS
In this study which is, at the best of our knowledge, the first double-bind, multicenter, randomized trial in this condition, L-arginine is not an effective treatment for severe vascular growth restriction.
Department of Perinatality, Obstetrics and Neonatology, Centre Hospitalier Universitaire, Nantes, France.
Norbert
N
Winer
Bernard
B
Branger
Elie
E
Azria
Vassilis
V
Tsatsaris
Henri-Jean
HJ
Philippe
Jean Christophe
JC
Rozé
Philippe
P
Descamps
Georges
G
Boog
Luc
L
Cynober
Dominique
D
Darmaun
D000328:Adult; D001120:Arginine / Q000627:therapeutic use*; D001724:Birth Weight / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D005317:Fetal Growth Retardation / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality*; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007236:Infant, Small for Gestational Age; D008297:Male; D009017:Morbidity; D009569:Nitric Oxide / Q000378:metabolism; D010920:Placenta / Q000098:blood supply* / Q000000981:diagnostic imaging; D011247:Pregnancy; D016896:Treatment Outcome; D016216:Ultrasonography, Prenatal; D014664:Vasodilation / Q000187:drug effects*
D009569:Nitric Oxide; D001120:Arginine