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

Sponsor
AGUNCO Obstetrics and Gynecology Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02016495
Collaborator
(none)
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Magnesium plus alpha-lipoic acid
  • Drug: Placebo
 Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Primary Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Magnesium + Lipoic Acid

Dietary Supplement: Magnesium plus alpha-lipoic acid
Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Number of women with sporadic episodes of preterm uterine contraction [From baseline (beginning of the treatment) until delivery]

  2. Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain [From baseline (beginning of the treatment) until delivery]

  3. Number of women needed for hospital admission for threatened preterm labour [From baseline (beginning of the treatment) until delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
23 Years to 41 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinica Villa delle Querce Naples Italy

Sponsors and Collaborators

  • AGUNCO Obstetrics and Gynecology Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT02016495
Other Study ID Numbers:
  • Mg-ALA
First Posted:
Dec 20, 2013
Last Update Posted:
Dec 20, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms:
Thioctic Acid

Study Results

No Results Posted as of Dec 20, 2013