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

NCT ID: NCT04874285

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2023-05-11

Brief Summary

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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

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Conditions

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Pregnancy, High Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control group

Women with risk factors for abortion, treated with progesterone

Group Type NO_INTERVENTION

No interventions assigned to this group

study group

Women with risk factors for abortion, treated with progesterone and a dietary supplement containing hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6

Group Type EXPERIMENTAL

HA

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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HA

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinica Alma Res

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HMW-HA_ABORTION

Identifier Type: -

Identifier Source: org_study_id

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