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

Efficacy of the Association of Hyaluronic Acid With High Molecular Weight, α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion in Patients at Risk

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 Overview

• Status: Completed
• Conditions: Abortion, Spontaneous
• Intervention / Treatment: Other: high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriele Saccone; Phone Number: +393394685179; Email: gabriele.saccone@unina.it

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche
    • Contact: Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Treatment group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.	3 months

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Spontaneous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Protective Agents; Micronutrients; Adjuvants, Immunologic; Bone Density Conservation Agents; Antioxidants; Vitamin B Complex; Viscosupplements; Vitamin D; Vitamins; Hyaluronic Acid; Thioctic Acid; Vitamin B 6; Pyridoxal; Pyridoxine
• Other Study ID Numbers: HA-PREV_22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No