The aim of the study is to assess the effect of a combination of Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in women at risk of preterm birth (PTB).
Signed informed consent
Fetal structural anomalies
Parallel
Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone
DrugParticipants randomized to the treatment arm will receive a combination oral supplement containing Magnesium (450 mg), Palmitoylethanolamide (200 mg), high-molecular-weight Hyaluronic Acid (200 mg), Vitamin B6 (2.6 mg), and Vitamin D (50 µg / 2000 IU), administered as two tablets per day. The supplement will be given in addition to standard vaginal progesterone (200 mg once daily). Treatment begins at enrollment (20-34 weeks' gestation) and continues until 37 weeks of gestati
Standard Treatment (Guideline-Based)
Other interventionParticipants randomized to the control arm will receive standard therapy consisting of vaginal progesterone (200 mg once daily) from enrollment (20-34 weeks' gestation) until 37 weeks of gestation. No additional supplements or investigational products will be administered.
Preterm Birth before 37 weeks
Proportion of participants who deliver before 37+0 weeks of gestation in each study arm.
Incidence of Preterm Uterine Contractions
Number of episodes of uterine contractions requiring clinical evaluation, as reported by participants or documented during hospital visits.
Emergency Department Visits for Preterm Contraction
Number of emergency department or obstetric triage visits due to symptoms of preterm uterine activity.
Interval From Treatment Initiation to Delivery
Number of days between study enrollment (start of therapy) and delivery.
Change in Cervical Length at 1 Week
Difference in transvaginal cervical length (mm) between baseline and 1 week after randomization.
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