High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion

NCT ID: NCT05449171

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion, Spontaneous

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment group

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HA-PREV_22

Identifier Type: -

Identifier Source: org_study_id

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