L-Arginine in Pre-Eclampsia

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research

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