Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy

Phase 3CompletedNCT00571766

University of Modena and Reggio Emilia80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypertension in Pregnancy

Interventions

L-ArginineDRUG

Oral L-Arginine 2g, twice a day for 14 weeks

PlaceboDRUG

Placebo 2 g twice a day for 14 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women between 18-20 week of gestation with chronic hypertension Exclusion Criteria: * Maternal or fetal disease

Locations (1)

University of Modena and Reggio Emilia

Modena, Emilia-Romagna, Italy

Outcomes

Primary Outcomes

to evaluate blood pressure changes in pregnant women with chronic hypertension during oral arginine or placebo treatment in second trimester of gestation.

Time frame: 14 weeks

Secondary Outcomes

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.

Time frame: 14 weeks

Data from ClinicalTrials.gov

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