PregnancyPhase 4NCT02016495
Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions
A Phase 4 study testing Magnesium plus alpha-lipoic acid in people with Pregnancy, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 41 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Magnesium plus alpha-lipoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 41 years
- Women only
- Adult
Who may be able to join
- 14-34 weeks of gestation
Who cannot join
- Preexisting diabetes mellitus
- Systolic blood pressure >140mm Hg
- Cancer
- lupus
- hepatitis
- HIV/AIDS
- Diagnosed alcohol or chemical dependency
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Magnesium plus alpha-lipoic acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium plus alpha-lipoic acidDietary supplement
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Magnesium + Lipoic Acid | Active comparator | Not described Receives: Dietary Supplement: Magnesium plus alpha-lipoic acid |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women with sporadic episodes of preterm uterine contraction
Measured: From baseline (beginning of the treatment) until delivery
Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain
Measured: From baseline (beginning of the treatment) until delivery
Number of women needed for hospital admission for threatened preterm labour
Measured: From baseline (beginning of the treatment) until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016495
- Sponsor's protocol ID
- Mg-ALA
- Status last verified
- Oct 2013
- First submitted
- 16 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions
- ClinicalTrials.gov ID
- NCT02016495
- Acronym / sponsor ID
- Mg-ALA
- Conditions
- Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Primary completion
- Feb 2013 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium + Lipoic Acid | Active comparator | Dietary Supplement: Magnesium plus alpha-lipoic acid |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 23 to 41 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 14-34 weeks of gestation
Key exclusion criteria (7 listed)
- Preexisting diabetes mellitus
- Systolic blood pressure >140mm Hg
- Cancer
- lupus
- hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium plus alpha-lipoic acid | Dietary supplement | Magnesium + Lipoic Acid |
| Placebo | Drug | Placebo |
Primary outcome
Number of women with sporadic episodes of preterm uterine contraction
Time frame: From baseline (beginning of the treatment) until delivery
Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain
Time frame: From baseline (beginning of the treatment) until delivery
Number of women needed for hospital admission for threatened preterm labour
Time frame: From baseline (beginning of the treatment) until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium plus alpha-lipoic acid in people with Pregnancy, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women with sporadic episodes of preterm uterine contraction (time frame: From baseline (beginning of the treatment) until delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.