L-Arginine in Pre-Eclampsia
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|ClinicalTrials.gov Identifier: NCT00157521|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 22, 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 or disease||Intervention/treatment||Phase|
|Pre-Eclampsia||Drug: L-arginine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
- NO production, at delivery
- Pregnancy outcome
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
|Hospital "Ospedali Riuniti", Unit of Obstetrics and Ginecology|
|Bergamo, Italy, 24128|
|Obstetrics and Ginecology Division|
|Brescia, Italy, 25100|
|Principal Investigator:||Piero Ruggenenti, MD||Mario Negri Institute|