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OpenTrials
Completed

NCT Number: NCT02016495

Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions

To evaluate whether a combined supplementation of magnesium and lipoic acid is able to significantly reduce the incidence of uterine contractions and related episodes of hospitalization in pregnant women.

Completed

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Key information

Conditions

Pregnancy

Age range

23 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Clinica Villa delle Querce

Naples, Italy

About this study

Primary prevention of preterm labor is based on the early identification of risk factors and on appropriate treatments. Although several drugs are currently used, the identification of effective and safe agents able to improve both maternal and fetal health is still warranted.

In this study the efficacy a formulation based on magnesium and alpha-lipoic acid has been compared with placebo to evaluate the incidence of reduction of preterm delivery.

Three hundred pregnant women at 14-34 weeks of gestation were enrolled and randomly divided to receive a daily single tablet containing magnesium and alpha-lipoic acid supplement or placebo until delivery.

Who can participate

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

Inclusion criteria

  • 14-34 weeks of gestation

Exclusion criteria

  • Preexisting diabetes mellitus
  • Systolic blood pressure >140mm Hg
  • Cancer
  • lupus
  • hepatitis
  • HIV/AIDS
  • Diagnosed alcohol or chemical dependency

Treatment and study plan

Magnesium plus alpha-lipoic acid

Dietary Supplement

Placebo

Drug

Primary outcomes

  1. Number of women with sporadic episodes of preterm uterine contraction

    Time frame: From baseline (beginning of the treatment) until delivery

  2. Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain

    Time frame: From baseline (beginning of the treatment) until delivery

  3. Number of women needed for hospital admission for threatened preterm labour

    Time frame: From baseline (beginning of the treatment) until delivery

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Important dates

Primary completion
2013
First posted
Dec 20, 2013
Registry last updated
Dec 20, 2013

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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