ClinicalTrials.gov
ClinicalTrials.gov Menu

L-Arginine in Pre-Eclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00157521
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 22, 2006
Sponsor:
Information provided by:
Mario Negri Institute for Pharmacological Research

Brief Summary:

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 or disease Intervention/treatment Phase
Pre-Eclampsia Drug: L-arginine Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2002
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. NO production, at delivery

Secondary Outcome Measures :
  1. Pregnancy outcome


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00157521     History of Changes
Other Study ID Numbers: L-ARG
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 22, 2006
Last Verified: December 2006

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