NCT05449171

Brief Summary

The study aims to verify if the association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, reduces the risk of miscarriage in patients at risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

June 30, 2022

Last Update Submit

February 21, 2024

Conditions

Abortion, Spontaneous

Outcome Measures

Primary Outcomes (1)

  • Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.

    3 months

Study Arms (2)

Control group

NO INTERVENTION

Treatment group

EXPERIMENTAL
Other: high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D

Interventions

high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin DOTHER

Patients will take an association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, from the first visit at the experimental center (within the 12th week of gestation) for 3 months.

Treatment group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • two or more previous spontaneous first trimester abortions without apparent risk factors (idiopathic polyabortion)
  • Endocrinopathies
  • Autoimmune diseases
  • Thrombophililic or coagulation diseases

You may not qualify if:

  • Multiple pregnancies
  • Presence of genetic abnormalities of one or both partners leading to increased risk of fetal aneuploidies
  • Presence of Mullerian abnormalities in the uterus
  • Symptoms present at recruitment such as pelvic pain or metrorrhagia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Thioctic AcidMagnesiumVitamin B 6Vitamin D

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipidsMetals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsPicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 8, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

January 31, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

IT(1)