NCT03952533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

May 14, 2019

Last Update Submit

May 17, 2022

Conditions

Cervical ShorteningPreterm Birth

Keywords

alpha-lipoic Acidvitamin Dcervical shorteningpretermbirthfood supplement

Outcome Measures

Primary Outcomes (3)

  • Cervical shortening

    Cervical shortening detected by the transvaginal ultrasound (TVS)

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

  • Rate of Short Cervix

    Rate of cervical length \< 25mm at the TVS exam

    at 19-21 weeks of Gestational age

  • Rate of Preterm birth

    Number of preterm birth occurred

    from 11-14 weeks to 37 weeks of Gestational age

Secondary Outcomes (2)

  • Accesses to the ET for Threatened PTB

    from 11-14 weeks to 37 weeks of Gestational age

  • Maternal hospitalization for threatened preterm labor

    from 11-14 weeks to 37 weeks of Gestational age

Study Arms (2)

ALA

EXPERIMENTAL

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

NO INTERVENTION

Control Group will be composed by women allocated in the "Control Group" and will not receive any supplementation but the standard care.

Interventions

DavDIETARY_SUPPLEMENT

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)

ALA

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparous,
  • Previous History of preterm birth,
  • Age between 18 - 41 years,
  • weeks of gestation,
  • BMI \< 18 kg/m2 or ≥ 30 kg/m2,
  • Uterine myoma,
  • Hypertensive disorders either chronic or induced by the pregnancy

You may not qualify if:

  • PPROM,
  • Cervical dilation ≥ 1 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Modena and Reggio Emilia

Modena, Mo, 41100, Italy

Location

Related Publications (6)

  • Shay KP, Moreau RF, Smith EJ, Smith AR, Hagen TM. Alpha-lipoic acid as a dietary supplement: molecular mechanisms and therapeutic potential. Biochim Biophys Acta. 2009 Oct;1790(10):1149-60. doi: 10.1016/j.bbagen.2009.07.026. Epub 2009 Aug 4.

    PMID: 19664690RESULT

  • Grandi G, Mueller M, Bersinger N, Papadia A, Nirgianakis K, Cagnacci A, McKinnon B. Progestin suppressed inflammation and cell viability of tumor necrosis factor-alpha-stimulated endometriotic stromal cells. Am J Reprod Immunol. 2016 Oct;76(4):292-8. doi: 10.1111/aji.12552. Epub 2016 Aug 12.

    PMID: 27515307RESULT

  • Kim HS, Kim HJ, Park KG, Kim YN, Kwon TK, Park JY, Lee KU, Kim JG, Lee IK. Alpha-lipoic acid inhibits matrix metalloproteinase-9 expression by inhibiting NF-kappaB transcriptional activity. Exp Mol Med. 2007 Feb 28;39(1):106-13. doi: 10.1038/emm.2007.12.

    PMID: 17334234RESULT

  • De-Regil LM, Palacios C, Lombardo LK, Pena-Rosas JP. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2016 Jan 14;(1):CD008873. doi: 10.1002/14651858.CD008873.pub3.

    PMID: 26765344RESULT

  • Okitsu O, Mimura T, Nakayama T, Aono T. Early prediction of preterm delivery by transvaginal ultrasonography. Ultrasound Obstet Gynecol. 1992 Nov 1;2(6):402-9. doi: 10.1046/j.1469-0705.1992.02060402.x.

    PMID: 12796914RESULT

  • Berghella V, Roman A, Daskalakis C, Ness A, Baxter JK. Gestational age at cervical length measurement and incidence of preterm birth. Obstet Gynecol. 2007 Aug;110(2 Pt 1):311-7. doi: 10.1097/01.AOG.0000270112.05025.1d.

    PMID: 17666605RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Monocentric open label randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

May 5, 2019

Primary Completion

September 25, 2020

Study Completion

June 1, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

IT(1)