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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016495
• Other study ID #: Mg-ALA
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2013
• Last updated: December 16, 2013

Study information

• Verified date: October 2013
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2013
• Gender: Female
• Age group: 23 Years to 41 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Magnesium plus alpha-lipoic acid

Drug:
• Placebo

Locations

Country	Name	City	State
Italy	Clinica Villa delle Querce	Naples

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women with sporadic episodes of preterm uterine contraction		From baseline (beginning of the treatment) until delivery
Primary	Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain		From baseline (beginning of the treatment) until delivery
Primary	Number of women needed for hospital admission for threatened preterm labour		From baseline (beginning of the treatment) until delivery