Prevenetion of Intrauterine Adhesions by Hyaluronic Acid GelNCT04975373
Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions
A study testing Intrauterine injection of hyaluronic acid in people with Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups. 1. study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity 2. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel
- What is being tested?
- Intrauterine injection of hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Jun 2021to 25 Jul 2022
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing hysteroscopic removal of retained placenta after delivery
Who cannot join
- Known adverse reaction or allergy to hyaluronic acid
- History of intrauterine adhesions
- Acute pelvic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Intrauterine Adhesions by Intrauterine Hyaluronic Acid Gel After Hysteroscopic Removal of Retained Products of Conception: Multicenter Prospective Randomized Trial
Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.
- study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
- control group - no injection
4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel.
during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.
- Being tested
- Intrauterine injection of hyaluronic acid
- Keywords
- retained placenta, operative hysteroscopy, intrauterine adhesions, hyaluronic acid
- Medical subject headings
- Placenta, Retained, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine injection of hyaluronic acidDrug
Also called operative hysteroscopy -, diagnostic hysteroscopy
operative hysteroscopy - as a part of treatment in cases with retained placenta after delivery diagnostic hysteroscopy - as a routine evaluation after removal of placenta
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | study group women in this group will receive intrauterine hyaluronic acid injection after operative hysteroscopy Receives: Drug: Intrauterine injection of hyaluronic acid |
| control group | No intervention | women will not receive hyaluronic acid after operative hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
any adhesions
presence of any adhesions in uterine cavity during diagnostic hysteroscopy
Measured: 4-8 weeks after intervention
Secondary outcomes (1)
adhesion scorring
American Fertility Society score for intrauterine adhesions
Measured: 4-8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start25 Jun 2021
- Primary completion25 Jul 2022 (estimated)
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevenetion of Intrauterine Adhesions by Hyaluronic Acid GelStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975373
- Sponsor's protocol ID
- 0002-21
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Intrauterine Adhesions by Intrauterine Hyaluronic Acid Gel After Hysteroscopic Removal of Retained Products of Conception: Multicenter Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04975373
- Acronym / sponsor ID
- 0002-21
- Keywords
- retained placenta, operative hysteroscopy, intrauterine adhesions, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 25 Jul 2022 (estimated)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 23 Jul 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.
Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.
- study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
- control group - no injection
4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel.
during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Drug: Intrauterine injection of hyaluronic acidstudy group women in this group will receive intrauterine hyaluronic acid injection after operative hysteroscopy |
| control group | No intervention | –women will not receive hyaluronic acid after operative hysteroscopy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing hysteroscopic removal of retained placenta after delivery
Key exclusion criteria (3 listed)
- Known adverse reaction or allergy to hyaluronic acid
- History of intrauterine adhesions
- Acute pelvic inflammatory disease
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 |
|---|---|---|
| Intrauterine injection of hyaluronic acidAlso: operative hysteroscopy -, diagnostic hysteroscopyoperative hysteroscopy - as a part of treatment in cases with retained placenta after delivery diagnostic hysteroscopy - as a routine evaluation after removal of placenta | Drug | study group |
Primary outcome
any adhesions
Time frame: 4-8 weeks after intervention
presence of any adhesions in uterine cavity during diagnostic hysteroscopy
1 secondary outcome
adhesion scorring
Time frame: 4-8 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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 Intrauterine injection of hyaluronic acid in people with Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel, run by Barzilai Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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 Israel. 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?
Results are not available in the source record.
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?
any adhesions (time frame: 4-8 weeks after intervention). 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 23 Jul 2021.