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

Sponsor

Lo.Li.Pharma s.r.l (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05449171

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abortion, Spontaneous	Other: high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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