High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion
Not Applicable
Completed
- Conditions
- Abortion, Spontaneous
- Interventions
- Other: high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D
- Registration Number
- NCT05449171
- Lead Sponsor
- Lo.Li.Pharma s.r.l
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D -
- Primary Outcome Measures
Name Time Method Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation. 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche
🇮🇹Napoli, Italy