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

NCT00549575 | Terminated Phase 3

• 1 other identifier: 99/4-A
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Severe Intra uterine growth retardation below the third centile with abnormal uterine doppler; Severe growth retardation with pathologic uterine Doppler; L-Arginine; Nitric Oxide Donor

Outcome Measures

Primary Outcomes (1)

• The principal outcome is birth weight at delivery and neonatal morbidity (Crib Score)

  6 weeks

Secondary Outcomes (1)

• Secondary outcomes are Maternal and fetal hemodynamic with blood pressure and dopplers upon inclusion, after 7 days of treatment and at delivery

  6 weeks

Study Arms (2)

A

EXPERIMENTAL

Patients received 14 g/day of L-arginine (90 mL syrup, Veyron France Laboratories). Doppler ultrasound examination of the uterine, umbilical and cerebral circulation, and of ductus venous was performed prior to inclusion, after 7 days of treatment, and the day before delivery. Ultrasound examination was performed upon randomization, and weekly until birth. Venous blood and urine samples were collected before initiation and after 7 days of treatment, and both maternal and umbilical venous samples were obtained at delivery for nitrate and nitrite (NO2-/ NO3-) determination.

Drug: L ARG

B

PLACEBO COMPARATOR

After double blind randomization, patients received a placebo. Doppler ultrasound examination of the uterine, umbilical and cerebral circulation, and of ductus venous was performed prior to inclusion, after 7 days of treatment, and the day before delivery. Ultrasound examination was performed upon randomization, and weekly until birth. Venous blood and urine samples were collected before initiation and after 7 days of treatment, and both maternal and umbilical venous samples were obtained at delivery for nitrate and nitrite (NO2-/ NO3-) determination.

Drug: Placebo

Interventions

L ARG DRUG

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

A

Placebo DRUG

After double blind randomization, patients received a placebo.

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Multicenter randomized trial.
• Patients with a singleton pregnancy with IUGR defined by fetal abdominal circumference less than or equal to the third percentile for gestational age, and abnormal uterine Doppler. Uterine Doppler was considered pathologic if Pourcelot's resistance index (S-D/S) was equal to or higher than 0.7, and/or if an obvious notch was present. If the placenta was not median, the side of the pathologic Doppler had to be on the same side as the placenta

You may not qualify if:

• Acute fetal distress
• Non vascular and non severe IUGR (normal uterine doppler scans and/or abdominal circumference \> 3rd percentile)
• Maternal immune disorder
• IUGR from an infectious etiology

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Chu-Nantes

Nantes, 44093, France

Location

Related Publications (1)

• Winer N, Branger B, Azria E, Tsatsaris V, Philippe HJ, Roze JC, Descamps P, Boog G, Cynober L, Darmaun D. L-Arginine treatment for severe vascular fetal intrauterine growth restriction: a randomized double-bind controlled trial. Clin Nutr. 2009 Jun;28(3):243-8. doi: 10.1016/j.clnu.2009.03.007. Epub 2009 Apr 8.

  PMID: 19359073 DERIVED

Study Officials

• Norbert Winer, Doctor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Dominique Darmaun, Professor

  Nantes University Hospital

  STUDY CHAIR

• Philippe Gilard, Doctor

  University Hospital, Angers

  STUDY CHAIR

• F Goffinet, Professor

  Paris-Port-Royal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: July 1, 2000
• Study Completion: June 1, 2006
• Last Updated: October 26, 2007

Record last verified: 2007-10

Locations

FR (1)