NCT04874285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

May 3, 2021

Last Update Submit

November 2, 2023

Conditions

Pregnancy, High Risk

Outcome Measures

Primary Outcomes (1)

  • reduction of the abortion rate

    rate of abortion

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

Study Arms (2)

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

HADIETARY_SUPPLEMENT

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

study group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Alma Res

Rome, 00198, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 5, 2021

Study Start

May 3, 2021

Primary Completion

May 30, 2022

Study Completion

May 11, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)