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

AGUNCO Obstetrics and Gynecology Centre

Status and phase: Completed; Phase 4

Conditions: Pregnancy

Treatments: Dietary Supplement: Magnesium plus alpha-lipoic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02016495

Mg-ALA

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 23 to 41 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

Magnesium + Lipoic Acid

Active Comparator group

Treatment:

Dietary Supplement: Magnesium plus alpha-lipoic acid

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo