Intrauterine Hyaluronic Acid Gel for Prevention of Intrau... | NCT04975373

Studies
Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions

NCT04975373

Sponsor

Barzilai Medical Center

Status

Unknown status

Last Update Posted

Jul 23, 2021Actual

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel

Interventions

Intrauterine injection of hyaluronic acid

Countries

Israel

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2021Actual

Primary Completion Date

Jul 25, 2022Estimated

Completion Date

Jul 25, 2022Estimated

First Submitted Date

Jul 14, 2021

First Submission Date that Met QC Criteria

Jul 14, 2021

First Posted Date

Jul 23, 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

Jul 14, 2021

Last Update Posted Date

Jul 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

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

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Other	study group women in this group will receive intrauterine hyaluronic acid injection after operative hysteroscopy	Drug: Intrauterine injection of hyaluronic acid
control group	No Intervention	women will not receive hyaluronic acid after operative hysteroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrauterine injection of hyaluronic acid	Drug	operative hysteroscopy - as a part of treatment in cases with retained placenta after delivery diagnostic hysteroscopy - as a routine evaluation after removal of placenta

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
any adhesions	presence of any adhesions in uterine cavity during diagnostic hysteroscopy	4-8 weeks after intervention

Secondary Outcomes

Measure	Description	Time Frame
adhesion scorring	American Fertility Society score for intrauterine adhesions	4-8 weeks after intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barzilai University Medical Center		Ashkelon			Israel

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

Condition Browse Module

MeSH Terms

ID	Term
D018457	Placenta, Retained
D006175	Gynatresia

Ancestor Terms

ID	Term
D010922	Placenta Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015907	Hysteroscopy

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided