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L-Arginine in Pre-Eclampsia

This study has been completed.
Sponsor:
Information provided by:
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT00157521
First received: September 8, 2005
Last updated: December 21, 2006
Last verified: December 2006
History of Changes
  Purpose

Pre-eclampsia is a disorder unique to pregnancy affecting both the mother and the fetus. Hypertension, proteinuria and edema are the most common and well-known maternal clinical symptoms. The incidence is approximately 6-8%. Pre-eclampsia is one of the leading causes of maternal and fetal mortality and morbidity associated with pregnancy throughout the world. The pathophysiology is unknown. At present, the most effective treatment is immediate delivery.

The researchers' studies contributed to the demonstration that the vasodilator nitric oxide (NO) is important for correct placentation and that less nitric oxide (NO)- dependent vasodilation and an excess formation of reactive oxygen species explain poor placenta perfusion in pre-eclampsia. This reduced NO activity and increased oxidative stress in pre-eclamptic placenta is related to low bioavailability of L-arginine, the NO precursor.

In this pilot study the researchers want to evaluate whether the administration of L-arginine to women with a clinical diagnosis of preeclampsia might restore physiological NO production in the placenta and ameliorate the pregnancy outcome.


Condition Intervention Phase
Pre-Eclampsia
 Drug: L-arginine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: A Double-Blind, Randomized, Pilot Study to Explore Whether Enhancing L-Arginine Bioavailability by Oral Supplementation Increases NO Production and Prevents Peroxynitrite Generation in the Pre-Eclamptic Placenta

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • NO production, at delivery

Secondary Outcome Measures:
  • Pregnancy outcome

Estimated Enrollment: 30
Study Start Date: September 2002
Estimated Study Completion Date: May 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pre-eclamptic women

    • Pregnancy – induced hypertension (diastolic blood pressure [DBP] ≥ 90 mm Hg) and
    • Proteinuria ≥ 300 mg/24 h or albuminuria ≥ 250 µg/min and/or
    • Early signs of intrauterine growth restriction (IUGR) more than 2 standard deviations below the mean for gestational age in patients with a previous ultrasound test before 20th week of gestation

  2. Normotensive pregnant women

    • Diastolic blood pressure < 90 mm Hg
    • No history of hypertension
    • No significant proteinuria
    • No signs of infection
    • No signs of IUGR
    • Matched for gestational age with pre-eclamptic women

Exclusion Criteria:

  • History of hypersensitivity to l-arginine
  • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of trial
  • Evidence of uncooperative attitude
  • Any evidence that allows predicting that the patient will not be able to complete the trial follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157521

Locations
Italy
Hospital "Ospedali Riuniti", Unit of Obstetrics and Ginecology
Bergamo, Italy, 24128
Obstetrics and Ginecology Division
Brescia, Italy, 25100
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Piero Ruggenenti, MD Mario Negri Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157521     History of Changes
Other Study ID Numbers: L-ARG
Study First Received: September 8, 2005
Last Updated: December 21, 2006
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on May 19, 2013