Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy

Phase 3

Completed

• Conditions: Hypertension in Pregnancy
• Interventions: Drug: Placebo; Drug: L-Arginine

• Registration Number: NCT00571766
• Lead Sponsor: University of Modena and Reggio Emilia

Brief Summary

The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women with chronic hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-09
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

• Maternal or fetal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo 2 g, 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 in pregnant women with chronic hypertension during oral arginine or placebo treatment in second trimester of gestation.	14 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate if is necessary add a conventional therapy for hypertension, to evaluate the maternal and fetal outcomes and possible complications, to evaluate the safety of L-Arginine.	14 weeks

Trial Locations

Locations (1)

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