Back to resultsIntrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions
Primary Purpose
Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intrauterine injection of hyaluronic acid
Sponsored by
About this trial
This is an interventional prevention trial for Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel focused on measuring retained placenta, operative hysteroscopy, intrauterine adhesions, hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- Women undergoing hysteroscopic removal of retained placenta after delivery
Exclusion Criteria:
- Known adverse reaction or allergy to hyaluronic acid
History of intrauterine adhesions
Acute pelvic inflammatory disease
Sites / Locations
- Barzilai University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
study group
control group
Arm Description
study group women in this group will receive intrauterine hyaluronic acid injection after operative hysteroscopy
women will not receive hyaluronic acid after operative hysteroscopy
Outcomes
Primary Outcome Measures
any adhesions
presence of any adhesions in uterine cavity during diagnostic hysteroscopy
Secondary Outcome Measures
adhesion scorring
American Fertility Society score for intrauterine adhesions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04975373
Brief Title
Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions
Official Title
Reduction of Intrauterine Adhesions by Intrauterine Hyaluronic Acid Gel After Hysteroscopic Removal of Retained Products of Conception: Multicenter Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Anticipated)
Study Completion Date
July 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barzilai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel
Keywords
retained placenta, operative hysteroscopy, intrauterine adhesions, hyaluronic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Other
Arm Description
study group women in this group will receive intrauterine hyaluronic acid injection after operative hysteroscopy
Arm Title
control group
Arm Type
No Intervention
Arm Description
women will not receive hyaluronic acid after operative hysteroscopy
Intervention Type
Drug
Intervention Name(s)
Intrauterine injection of hyaluronic acid
Other Intervention Name(s)
operative hysteroscopy -, diagnostic hysteroscopy
Intervention Description
operative hysteroscopy - as a part of treatment in cases with retained placenta after delivery diagnostic hysteroscopy - as a routine evaluation after removal of placenta
Primary Outcome Measure Information:
Title
any adhesions
Description
presence of any adhesions in uterine cavity during diagnostic hysteroscopy
Time Frame
4-8 weeks after intervention
Secondary Outcome Measure Information:
Title
adhesion scorring
Description
American Fertility Society score for intrauterine adhesions
Time Frame
4-8 weeks after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women undergoing hysteroscopic removal of retained placenta after delivery
Exclusion Criteria:
Known adverse reaction or allergy to hyaluronic acid
History of intrauterine adhesions
Acute pelvic inflammatory disease
Facility Information:
Facility Name
Barzilai University Medical Center
City
Ashkelon
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions
We'll reach out to this number within 24 hrs