L-arginine Effects on Chronic Hypertension in Pregnancy

Phase 3

Completed

• Conditions: Hypertension in Pregnancy
• Interventions: Other: placebo; Drug: L-arginine

• Registration Number: NCT00974714
• Lead Sponsor: University of Modena and Reggio Emilia

Brief Summary

The purpose of this study is to evaluate the effects of oral L-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2009-06
• Status Verified: 2009-09
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Study Completion: 2009-12
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Pregnant women between 18-20 weeks of gestation with chronic hypertension

Exclusion Criteria

• Other maternal or fetal systemic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	oral placebo twice a day for 14 weeks
1	L-arginine	Oral L-arginine 2 g twice a day, for 14 weeks

Primary Outcome Measures

Name	Time	Method
to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation	14 weeks

Secondary Outcome Measures

Name	Time	Method
evaluate if is necessary to add a conventional therapy for hypertension, to evaluate pregnancy outcomes and eventual complications, to evaluate safety of oral L-arginine administration	14 weeks

Trial Locations

Locations (1)

University of Modena and Reggio Emilia; 🇮🇹 Modena, Mo, Italy