α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D and Risk Factor for Pre-term Birth (ALA)
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|ClinicalTrials.gov Identifier: NCT03952533|
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 18, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cervical Shortening Preterm Birth||Dietary Supplement: Dav||Not Applicable|
The physiological course of pregnancy can be threatened by the onset of rhythmic and progressive uterine contractions, associated with a shortening and dilation of the cervix.
These modifications occur as a consequence of inflammatory processes that involve important changes in the extracellular matrix of connective tissues. For this reason, in the event of a threat of preterm birth, the appropriate tocolytic therapies should be associated with interventions able to counteract morphological changes in the uterine cervix. Women presenting high or low BMI, presence of uterine myomas, metrorrhagia during the first trimester and hypertensive disorders are at risk for PTB. Current management practices remain profoundly various, without a therapeutic tocolytic strategy, especially because most of the first-line tocolytic drugs used present important side effects . It is to be assessed whether a supplementation during pregnancy with minerals, vitamins, anti-inflammatory and anti-oxidant agents can avoid PTB in women with risk factors.
ALA may interact synergistically with magnesium, vitamin B6 and vitamin D, limiting some of the main factors related to the risk of preterm delivery - probably via the inhibition of nuclear factor k beta (NF-kB)-signaling pathway - and reducing therefore the rate of uterine contractions.
Moreover, the administration of ALA, magnesium, vitamin B6 and vitamin D have been demonstrated to be safe in pregnancy.
The aim of the present study is to evaluate whether pregnant women presenting risk factors for PTB, treated with a combination of ALA, magnesium, vitamin 6 and vitamin D from 11-14 weeks of gestational age, until delivery, could present a reduced rate of cervical shortening measured by transvaginal ultrasound (TVS) at 11-14 weeks and 19-21 weeks of gestational age.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Monocentric open label randomized controlled study|
|Masking:||None (Open Label)|
|Official Title:||Effects of the Supplementation of α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D to Women Presenting Risk Factor for Pre-term Birth|
|Actual Study Start Date :||May 5, 2019|
|Actual Primary Completion Date :||September 25, 2020|
|Actual Study Completion Date :||June 1, 2021|
ALA Group will be composed of women allocated to the "Treatment Group". These women will receive 2 tablets of Alpha lipoic Acid (ALA) as Dav® food supplement 1,2 g (Dav®, Lo.Li. Pharma, Rome, Italy) daily until delivery.
Dietary Supplement: Dav
Daily oral administration of a food supplement constituted by α-lipoic acid, magnesium, vitamin B6 and vitamin D in tablets of 1,2 g (Dav®, Lo.Li. Pharma, Rome, Italy)
No Intervention: Control
Control Group will be composed by women allocated in the "Control Group" and will not receive any supplementation but the standard care.
- Cervical shortening [ Time Frame: from 11-14 weeks to 19-21 weeks of Gestational age ]Cervical shortening detected by the transvaginal ultrasound (TVS)
- Rate of Short Cervix [ Time Frame: at 19-21 weeks of Gestational age ]Rate of cervical length < 25mm at the TVS exam
- Rate of Preterm birth [ Time Frame: from 11-14 weeks to 37 weeks of Gestational age ]Number of preterm birth occurred
- Accesses to the ET for Threatened PTB [ Time Frame: from 11-14 weeks to 37 weeks of Gestational age ]Number of accesses to the ER for threatened PTB due to episodes of preterm uterine contractions and/or cervical shortening
- Maternal hospitalization for threatened preterm labor [ Time Frame: from 11-14 weeks to 37 weeks of Gestational age ]Maternal need for hospital admission for threatened preterm labor
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|Ages Eligible for Study:||18 Years to 41 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Pregnant Women|
|Accepts Healthy Volunteers:||No|
- Previous History of preterm birth,
- Age between 18 - 41 years,
- 11-14 weeks of gestation,
- BMI < 18 kg/m2 or ≥ 30 kg/m2,
- Uterine myoma,
- Hypertensive disorders either chronic or induced by the pregnancy
- Cervical dilation ≥ 1 cm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952533
|University of Modena and Reggio Emilia|
|Modena, Mo, Italy, 41100|
|Responsible Party:||Prof. Fabio Facchinetti, Full Professor, University of Modena and Reggio Emilia|
|Other Study ID Numbers:||
|First Posted:||May 16, 2019 Key Record Dates|
|Last Update Posted:||May 18, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
All information required for this study in a manner strictly reserved to the norms of Good Clinical Practice (Legislative Decree 211/2003), as well as those relating to personal and sensitive data, c.d. Privacy Code (Legislative Decree 196/2003).
Personal data, including sensitive data, will be associated with a code, from which it will be impossible to trace back to its identity: only the investigating doctor will be able to link the code to his name.
The Specialist Doctor who follows the profession in the study, the people in charge of monitoring the study and the Regulatory Authorities have access to personal data, in compliance with and with the Guidelines of the Guarantor for the protection of personal data (Resolution No. 52 of 24 / 07/2008 and subsequent amendments and additions). The staff in charge of the study is in any case obliged to maintain the confidentiality of such information.
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Obstetric Labor, Premature
Obstetric Labor Complications