Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07305519

The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:

Led by University of Roma La Sapienza · Updated on 2026-04-29

150

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Singleton pregnancy
  • Maternal age 63 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Policlinico Umberto I

Rome, RM, Italy, 00161

Actively Recruiting

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Research Team

G

Giuseppe RIZZO, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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