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NCT04874285 Clinical Trial

Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.

Pregnancy, High Risk Clinical Trial

Official title:
Supplementation With Hyaluronic Acid, Alpha-lipoic Acid, Magnesium, and Vitamin D and B6 in Patients at Risk of Abortion Treated With Progesterone: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04874285
Other study ID # HMW-HA_ABORTION
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date May 11, 2023

Study information
Verified date November 2023
Source Lo.Li.Pharma s.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The trial aims to investigate the effect of supplementation with hyaluronic acid, alpha-lipoic acid, magnesium, vitamin D and vitamin B6 in progesterone-treated pregnant women with risk factors for abortion.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date May 11, 2023
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures) Exclusion Criteria: - Other pregnancy-related conditions - Diabetes or hypertension - Concomitant pharmacological therapies (anticoagulant or antihypertensive) - Use of tocolytic drugs two months prior to enrollment - Association with hypoglycemic drugs

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• HA
hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6

Locations
Country Name City State
Italy Clinica Alma Res Rome

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary reduction of the abortion rate rate of abortion 1 day (single time-point before week 20 of gestation)
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