Magnesium, PEA, high‑molecular‑weight hyaluronic acid, vitamin B6, and vitamin D to help prevent preterm birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol gives women with a singleton pregnancy and a transvaginal cervical length of 15–30 mm between 20+0 and 34+0 weeks a combination regimen of magnesium, PEA, high‑molecular‑weight hyaluronic acid, vitamin B6, and vitamin D alongside guideline-based vaginal progesterone and compares outcomes to standard treatment alone. The rationale is that these molecules may reduce inflammation, support uterine quiescence, and improve cervical integrity through multiple biochemical pathways. Participants with major maternal or fetal comorbidities, multiple gestation, or PROM are excluded. Outcomes will focus on rates of preterm birth and related neonatal morbidity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent

Singleton pregnancy

Maternal age ≥ 18 years

Gestational age between 20+0 and 34+0 weeks at enrollment

Cervical length between 15 mm and 30 mm measured by transvaginal ultrasound

Exclusion Criteria:

* Fetal structural anomalies

Maternal chronic diseases or pregnancy-related conditions, including diabetes, hypertension, preeclampsia, cardiovascular disease, infections, or autoimmune disorders

Multiple gestation

Fetal growth abnormalities (estimated fetal weight \<10th or \>90th percentile)

Prelabor rupture of membranes (PROM)

Where it's running

• Policlinico Umberto I
  Rome, Rm, Italy Recruiting

Study contacts

• Study coordinator: Giuseppe RIZZO, Professor
• Email: giuseppe.rizzo@uniroma1.it
• Phone: +393386973001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.