Use of Dietary Supplements in Patients at Risk of Abortio... | NCT04874285

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

NCT04874285

Sponsor

Lo.Li.Pharma s.r.l

Status

Completed

Last Update Posted

Nov 3, 2023Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Pregnancy, High Risk

Interventions

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2021Actual

Primary Completion Date

May 30, 2022Actual

Completion Date

May 11, 2023Actual

First Submitted Date

May 3, 2021

First Submission Date that Met QC Criteria

May 4, 2021

First Posted Date

May 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2023

Last Update Posted Date

Nov 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	No Intervention	Women with risk factors for abortion, treated with progesterone
study group	Experimental	Women with risk factors for abortion, treated with progesterone and a dietary supplement containing hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6	Dietary Supplement: HA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HA	Dietary Supplement	hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction of the abortion rate	rate of abortion	1 day (single time-point before week 20 of gestation)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Clinica Alma Res		Rome		00198	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided