Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions

NCT04975373 | Unknown

• 1 other identifier: 0002-21
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.

1. 1.study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
2. 2.control group - no injection

Conditions

Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel

Keywords

retained placenta; operative hysteroscopy; intrauterine adhesions; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• any adhesions

  presence of any adhesions in uterine cavity during diagnostic hysteroscopy

  4-8 weeks after intervention

Secondary Outcomes (1)

• adhesion scorring

  4-8 weeks after intervention

Study Arms (2)

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

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

Also known as: operative hysteroscopy -, diagnostic hysteroscopy

study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing hysteroscopic removal of retained placenta after delivery

You may not qualify if:

• Known adverse reaction or allergy to hyaluronic acid
• History of intrauterine adhesions
• Acute pelvic inflammatory disease

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilai University Medical Center

Ashkelon, Israel

Location

MeSH Terms

Conditions

Placenta, Retained; Gynatresia

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

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

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: June 25, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)