NCT02016495

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
Last Updated

December 20, 2013

Status Verified

October 1, 2013

First QC Date

December 16, 2013

Last Update Submit

December 16, 2013

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Magnesium + Lipoic Acid

ACTIVE COMPARATOR
Dietary Supplement: Magnesium plus alpha-lipoic acid

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Magnesium plus alpha-lipoic acidDIETARY_SUPPLEMENT
Magnesium + Lipoic Acid
PlaceboDRUG
Placebo

Eligibility Criteria

Age23 Years - 41 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

  • weeks of gestation

You may not qualify if:

  • Preexisting diabetes mellitus
  • Systolic blood pressure \>140mm Hg
  • Cancer
  • lupus
  • hepatitis
  • HIV/AIDS
  • Diagnosed alcohol or chemical dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Villa delle Querce

Naples, Italy

Location

MeSH Terms

Interventions

MagnesiumThioctic Acid

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsCarboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Primary Completion

February 1, 2013

Last Updated

December 20, 2013

Record last verified: 2013-10

Locations

IT(1)