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L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial (L Arginine in IUGR)

NCT00549575 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2007-10-26

No results posted yet for this study

Summary

Although there is a strong rationale to supplement gravid patients suffering intrauterine growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors, evidence in the literature has been inconclusive. The current study was designed to determine whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth restriction (IUGR).

Conditions

  • Intra Uterine Growth Retardation

Interventions

DRUG

L ARG

Patients received 14 g/day of L-arginine (90 mL syrup, Veyron France Laboratories).

DRUG

Placebo

After double blind randomization, patients received a placebo.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Norbert Winer, Doctor · Nantes University Hospital

  • Dominique Darmaun, Professor · Nantes University Hospital

  • Philippe Gilard, Doctor · University Hospital, Angers

  • F Goffinet, Professor · Paris-Port-Royal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Completion
2006-06-30

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549575 on ClinicalTrials.gov