CompletedNot Applicable

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

Italy122 participantsStarted 2019-05-05

Plain-language 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.

Who can participate

Age range18 Years – 41 Years

SexFEMALE

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Inclusion criteria

✓. Nulliparous,
✓. 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

Exclusion criteria

✕. PPROM,
✕. Cervical dilation ≥ 1 cm

What they're measuring

Cervical shortening

Timeframe: from 11-14 weeks to 19-21 weeks of Gestational age

Rate of Short Cervix

Timeframe: at 19-21 weeks of Gestational age

Rate of Preterm birth

Timeframe: from 11-14 weeks to 37 weeks of Gestational age

Trial details

NCT IDNCT03952533

SponsorUniversity of Modena and Reggio Emilia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-25

View on ClinicalTrials.gov More Cervical Shortening trials