An interventional study of Dav in Cervical Shortening and Preterm Birth, sponsored by University of Modena and Reggio Emilia. Completed at 1 site in Italy. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Modena and Reggio Emilia · Not applicable, Interventional, and Prevention
Effects of oral administration of a food supplement constituted by α-lipoic acid, magnesium, vitamin B6 and vitamin D in tablets of 1,2 g administered daily to women presenting risk factors for preterm birth (PTB). The aim is to reduce the rate of short cervix at 19-21 weeks of gestational age and consequently reduce the occurrence of PTB.
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 [8]. 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.
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 122 is above the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Modena and Reggio Emilia is the lead sponsor of 65 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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
Control Group will be composed by women allocated in the "Control Group" and will not receive any supplementation but the standard care.
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)
Cervical shortening
Cervical shortening detected by the transvaginal ultrasound (TVS)
Time frame: from 11-14 weeks to 19-21 weeks of Gestational age
Rate of Short Cervix
Rate of cervical length \< 25mm at the TVS exam
Time frame: at 19-21 weeks of Gestational age
Rate of Preterm birth
Number of preterm birth occurred
Time frame: from 11-14 weeks to 37 weeks of Gestational age
Accesses to the ET for Threatened PTB
Number of accesses to the ER for threatened PTB due to episodes of preterm uterine contractions and/or cervical shortening
Time frame: from 11-14 weeks to 37 weeks of Gestational age
Maternal hospitalization for threatened preterm labor
Maternal need for hospital admission for threatened preterm labor
Time frame: from 11-14 weeks to 37 weeks of Gestational age
Plan to share: 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.
Ran from May 2019 to primary completion in Sep 2020, 16 months.
Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 16 months is below that.
Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Modena and Reggio Emilia