Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-02-13 @ 12:34 PM
Study NCT ID:
NCT02016495
Status:
COMPLETED
Last Update Posted:
2013-12-20
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions
Sponsor:
AGUNCO Obstetrics and Gynecology Centre
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: