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

Phase 4

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Magnesium plus alpha-lipoic acid; Drug: Placebo

• Registration Number: NCT02016495
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

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.

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 Timeline

• Primary Completion: 2013-02
• Status Verified: 2013-10
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-16
• Last Update Submitted: 2013-12-16
• Study First Posted: 2013-12-20
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Magnesium + Lipoic Acid	Magnesium plus alpha-lipoic acid	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain	From baseline (beginning of the treatment) until delivery
Number of women with sporadic episodes of preterm uterine contraction	From baseline (beginning of the treatment) until delivery
Number of women needed for hospital admission for threatened preterm labour	From baseline (beginning of the treatment) until delivery

Trial Locations

Locations (1)

Clinica Villa delle Querce; 🇮🇹 Naples, Italy