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

Lo.Li.Pharma s.r.l100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Abortion, Spontaneous

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche

Naples, Italy

Outcomes

Primary Outcomes

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

Time frame: 3 months

Data from ClinicalTrials.gov

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