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OpenTrials
Completed

NCT Number: NCT04874285

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

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.

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Key information

Conditions

Pregnancy, High Risk

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Alma Res

Rome, 00198, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HA

Dietary Supplement

hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6

Primary outcomes

  1. reduction of the abortion rate

    Time frame: 1 day (single time-point before week 20 of gestation)

    rate of abortion

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 5, 2021
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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