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L-arginine Effects on Chronic Hypertension in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00974714
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
University of Modena
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertension in Pregnancy Drug: L-arginine Other: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral L-arginine on Chronic Hypertension in Pregnancy
Study Start Date : September 2007
Primary Completion Date : June 2009
Study Completion Date : December 2009


Arm Intervention/treatment
Experimental: 1
Oral L-arginine 2 g twice a day, for 14 weeks
Drug: L-arginine
Oral L-arginine 2 g twice a day for 14 weeks
Placebo Comparator: 2
oral placebo twice a day for 14 weeks
Other: placebo
oral placebo 2 g twice a day for 14 weeks



Primary Outcome Measures :
  1. to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 14 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other maternal or fetal systemic disease

Information from the National Library of Medicine

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): NCT00974714


Locations
Italy
University of Modena and Reggio Emilia
Modena, Emilia Romagna, Italy, 41100
University of Modena and Reggio Emilia
Modena, Mo, Italy, 41100
Sponsors and Collaborators
University of Modena and Reggio Emilia
University of Modena

Responsible Party: Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT00974714     History of Changes
Other Study ID Numbers: Facchinetti
Neri Isabella ( Other Grant/Funding Number: Fabio Facchinetti )
De Pace Viviana ( Other Grant/Funding Number: Fabio Facchinetti )
Monari Francesca ( Other Grant/Funding Number: Fabio Facchinetti )
Dante Giulia ( Other Grant/Funding Number: Fabio Facchinetti )
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: September 2009

Keywords provided by University of Modena and Reggio Emilia:
chronic hypertension in pregnancy

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications