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

NCT ID: NCT02016495

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Study Groups

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Magnesium + Lipoic Acid

Group Type ACTIVE_COMPARATOR

Magnesium plus alpha-lipoic acid

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Magnesium plus alpha-lipoic acid

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AGUNCO Obstetrics and Gynecology Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinica Villa delle Querce

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Mg-ALA

Identifier Type: -

Identifier Source: org_study_id