This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

L-Arginine in Pre-Eclampsia

This study has been completed.
Information provided by:
Mario Negri Institute for Pharmacological Research Identifier:
First received: September 8, 2005
Last updated: December 21, 2006
Last verified: December 2006

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
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:

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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00157521

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
Principal Investigator: Piero Ruggenenti, MD Mario Negri Institute
  More Information Identifier: NCT00157521     History of Changes
Other Study ID Numbers: L-ARG
Study First Received: September 8, 2005
Last Updated: December 21, 2006

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications processed this record on June 22, 2017