Actively Recruiting
The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth: A Randomized Controlled Trial
Led by University of Roma La Sapienza · Updated on 2026-04-29
150
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Preterm birth (PTB) is a major cause of health problems for newborns worldwide. Researchers are studying whether a combination of natural substances—Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D—can help prevent early labor in women at risk. This randomized, open-label pilot study will assess if adding these supplements to the standard vaginal progesterone treatment reduces the chance of delivering before 37 weeks in women with a shorter cervix during mid-to-late pregnancy. Participants will be divided into two groups: one will receive standard care with vaginal progesterone alone, while the other will take vaginal progesterone plus an oral supplement containing the five natural compounds. The supplement is given as two tablets daily from enrollment between 20 and 34 weeks of pregnancy until 37 weeks. The study will follow women until delivery or 37 weeks gestation. Women will have their cervical length measured at the start, and again one and two weeks later. The study will track the timing of birth, the occurrence of preterm contractions, emergency visits due to contractions, and cervical changes over time. This pilot trial aims to provide early data to guide future, larger studies on preventing preterm birth using this combination treatment.
CONDITIONS
Brief Title
The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:
Who Can Participate
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment (20 to 34 weeks' gestation) until 37 weeks of gestation
Participants receive either a combination oral supplement containing Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in addition to standard vaginal progesterone, or standard vaginal progesterone alone, starting from enrollment until 37 weeks of gestation.
3 visits for cervical length assessment (baseline, 1 week, and 2 weeks after enrollment)
Trial Site Locations
Total: 1 location
1
Policlinico Umberto I
Rome, RM, Italy, 00161
Actively Recruiting
Research Team
G
Giuseppe RIZZO, Professor
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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