Pregnancy, High RiskNCT04874285
Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.
A study testing HA in people with Pregnancy, High Risk, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk
- What is being tested?
- HA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2021to 11 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Conditions
- Pregnancy, High Risk
- Being tested
- HA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HADietary supplement
hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the abortion rate
rate of abortion
Measured: 1 day (single time-point before week 20 of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start3 May 2021
- Primary completion30 May 2022
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874285
- Sponsor's protocol ID
- HMW-HA_ABORTION
- Status last verified
- Nov 2023
- First submitted
- 3 May 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04874285
- Acronym / sponsor ID
- HMW-HA_ABORTION
- Conditions
- Pregnancy, High Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Women with risk factors for abortion, treated with progesterone |
| study group | Experimental | Dietary Supplement: HAWomen with risk factors for abortion, treated with progesterone and a dietary supplement containing hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAhyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6 | Dietary supplement | study group |
Primary outcome
reduction of the abortion rate
Time frame: 1 day (single time-point before week 20 of gestation)
rate of abortion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA in people with Pregnancy, High Risk, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of the abortion rate (time frame: 1 day (single time-point before week 20 of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.