Cervical Shortening, Preterm Birth
Conditions
Keywords
alpha-lipoic Acid, vitamin D, cervical shortening, pretermbirth, food supplement
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTDav
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)
Sponsors
University of Modena and Reggio Emilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Monocentric open label randomized controlled study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No
Inclusion criteria
1. Nulliparous, 2. Previous History of preterm birth, 3. Age between 18 - 41 years, 4. 11-14 weeks of gestation, 5. BMI \< 18 kg/m2 or ≥ 30 kg/m2, 6. Uterine myoma, 7. Hypertensive disorders either chronic or induced by the pregnancy
Exclusion criteria
1. PPROM, 2. Cervical dilation ≥ 1 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical shortening | from 11-14 weeks to 19-21 weeks of Gestational age | Cervical shortening detected by the transvaginal ultrasound (TVS) |
| Rate of Short Cervix | at 19-21 weeks of Gestational age | Rate of cervical length \< 25mm at the TVS exam |
| Rate of Preterm birth | from 11-14 weeks to 37 weeks of Gestational age | Number of preterm birth occurred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accesses to the ET for Threatened PTB | 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 | from 11-14 weeks to 37 weeks of Gestational age | Maternal need for hospital admission for threatened preterm labor |
Countries
Italy
Outcome results
None listed