α-lipoic Acid (ALA), Magnesium, Vitamin B6 & Vitamin D & Risk Factor for

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03952533
Study type	Interventional
Source	University of Modena and Reggio Emilia
Contact
Status	Completed
Phase	N/A
Start date	May 5, 2019
Completion date	June 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Completed	`NCT05502510` - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Completed	`NCT02993744` - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone	N/A
Active, not recruiting	`NCT02673216` - Infection and Adverse Pregnancy Outcome
Completed	`NCT01683565` - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood	Phase 4
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT01412931` - Protein and Ultrasound Indicators of Preterm Birth	N/A
Completed	`NCT02606058` - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?	N/A
Terminated	`NCT03715530` - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women	N/A
Completed	`NCT00422526` - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial	Phase 3
Enrolling by invitation	`NCT04251260` - Effectiveness of Positioning in Preterm Neonates	N/A
Completed	`NCT03668860` - India Dexamethasone and Betamethasone	Phase 1
Recruiting	`NCT03638037` - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed	`NCT02225353` - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery	Phase 2
Recruiting	`NCT03992534` - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth	Phase 1
Completed	`NCT03144141` - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery	N/A
Completed	`NCT05210985` - Examination of the Relationship Between Home Affordances With Development
Completed	`NCT04021654` - What is the Future of Vulnerable New-borns

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D and Risk Factor for Pre-term Birth — ALA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms