Abortion, Spontaneous
Conditions
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.
Interventions
OTHERhigh 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.
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation. | 3 months |
Countries
Italy
Outcome results
None listed