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

NCT07305519 | Recruiting

• 1 other identifier: PEATB_2025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Preterm Labor

Keywords

preterm labor; preterm birth; prematurity; magnesium; hyaluronic acid; vitamin B6; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Preterm Birth before 37 weeks

  Proportion of participants who deliver before 37+0 weeks of gestation in each study arm.

  Up to 37 weeks of gestation or delivery, whichever occurs first.

Secondary Outcomes (5)

• Incidence of Preterm Uterine Contractions

  From enrollment until 37 weeks of gestation or delivery.

• Emergency Department Visits for Preterm Contraction

  From enrollment until 37 weeks of gestation or delivery.

• Interval From Treatment Initiation to Delivery

  From baseline (T0) to delivery.

• Change in Cervical Length at 1 Week

  Baseline (T0) and 1 week (T1).

• Change in Cervical Length at 2 Weeks

  Baseline (T0) and 2 weeks (T2).

Study Arms (2)

Treatment: Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone

EXPERIMENTAL

Drug: Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone

Control: Vaginal Progesterone Only

ACTIVE COMPARATOR

Other: Standard Treatment (Guideline-Based)

Interventions

Standard Treatment (Guideline-Based) OTHER

Participants 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.

Control: Vaginal Progesterone Only

Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone DRUG

Participants 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

Treatment: Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, RM, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Giuseppe RIZZO, Professor

CONTACT

+393386973001; giuseppe.rizzo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Giuseppe Rizzo

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

IT (1)