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

Not Applicable

Completed

• Conditions: Pregnancy, High Risk
• Interventions: Dietary Supplement: HA

• Registration Number: NCT04874285
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-05
• Primary Completion: 2022-05-30
• Study Completion: 2023-05-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	HA	Women with risk factors for abortion, treated with progesterone and a dietary supplement containing hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6

Primary Outcome Measures

Name	Time	Method
reduction of the abortion rate	1 day (single time-point before week 20 of gestation)	rate of abortion

Trial Locations

Locations (1)

Clinica Alma Res; 🇮🇹 Rome, Italy