Magnesium, PEA, high‑molecular‑weight hyaluronic acid, vitamin B6, and vitamin D to help prevent preterm birth
The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth: A Randomized Controlled Trial
This treatment will try a daily combination of magnesium, palmitoylethanolamide (PEA), high‑molecular‑weight hyaluronic acid, vitamin B6, and vitamin D together with vaginal progesterone in pregnant women with a short cervix (15–30 mm) between 20+0 and 34+0 weeks to see if it lowers the chance of preterm birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT07305519 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18 or older with a singleton pregnancy between 20+0 and 34+0 weeks and a transvaginal cervical length of 15–30 mm who can provide informed consent are the intended candidates.
Not a fit: Women with multiple pregnancies, prelabor rupture of membranes, major fetal anomalies, significant maternal chronic disease, or pregnancy complications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could reduce preterm births and related neonatal complications in women with a short cervix.
How similar studies have performed: Individual components such as magnesium, hyaluronic acid, and PEA have shown promising anti-inflammatory or cervical-support effects in prior research, but the specific combined regimen is novel and has not been widely tested for preventing preterm birth.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome, RM
- Policlinico Umberto I — Rome, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe RIZZO, Professor
- Email: giuseppe.rizzo@uniroma1.it
- Phone: +393386973001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.