Pregnancy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMagnesium plus alpha-lipoic acid
DRUGPlacebo
Sponsors
AGUNCO Obstetrics and Gynecology Centre
Eligibility
Sex/Gender
FEMALE
Age
23 Years to 41 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of women with sporadic episodes of preterm uterine contraction | From baseline (beginning of the treatment) until delivery |
| 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 needed for hospital admission for threatened preterm labour | From baseline (beginning of the treatment) until delivery |
Countries
Italy
Outcome results
None listed