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Completed

NCT Number: NCT00974714

L-arginine Effects on Chronic Hypertension in Pregnancy

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.

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Modena and Reggio Emilia, Modena, Emilia-Romagna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Other maternal or fetal systemic disease

Treatment and study plan

L-arginine

Drug

Oral L-arginine 2 g twice a day for 14 weeks

Placebo

Other

oral placebo 2 g twice a day for 14 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Official study title

Effects of Oral L-arginine on Chronic Hypertension in Pregnancy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2009
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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