L-Arginine in Pre-Eclampsia

NCT00157521 | Completed Phase 3

• 1 other identifier: L-ARG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• NO production, at delivery

Secondary Outcomes (1)

• Pregnancy outcome

Interventions

L-arginine DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (2)

Hospital "Ospedali Riuniti", Unit of Obstetrics and Ginecology

Bergamo, Bergamo, 24128, Italy

Location

Obstetrics and Ginecology Division

Brescia, 25100, Italy

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Arginine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Piero Ruggenenti, MD

  Mario Negri Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: ECT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2002
• Study Completion: May 1, 2006
• Last Updated: December 22, 2006

Record last verified: 2006-12

Locations

IT (2)