Status:
COMPLETED
L-Arginine in Pre-Eclampsia
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Pre-Eclampsia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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 incidenc...
Detailed Description
INTRODUCTION In the past few years evidence has accumulated strongly suggesting that nitric oxide (NO), a potent endothelial-derived vasodilator, might be implicated in gestational vasodilatation. NO...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00157521
Start Date
September 1 2002
End Date
May 1 2006
Last Update
December 22 2006
Active Locations (2)
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1
Hospital "Ospedali Riuniti", Unit of Obstetrics and Ginecology
Bergamo, Bergamo, Italy, 24128
2
Obstetrics and Ginecology Division
Brescia, Italy, 25100