Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy

Nadezhda Women's Health Hospital

Status: Enrolling

Conditions: Intrauterine Adhesion

Treatments: Drug: Heparin solution; Drug: Anti-adhesion barrier gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05257213

3/11022022

Details and patient eligibility

About

The aim of this study is to compare the efficacy of intrauterine application of heparin solution to the use of hyaluronic acid barrier gel for the prevention of intrauterine adhesion formation after operative hysteroscopy.

Full description

In this trial the investigators aim to evaluate and compare the effect of heparin solution to anti-adhesive hyaluronic barrier gel administration immediately after operative hysteroscopy on post-surgical complications (incidence, extent and severity of intrauterine adhesions, abnormal menstrual cycle pattern) and fertility.

Patients undergoing operative hysteroscopy will be identified and invited to participate in the trial. At 4 to 8 weeks after the initial surgery, a follow-up, diagnostic hysteroscopy will be performed to identify indications for subsequent operative procedure and classify intrauterine adhesions according to extent of uterine cavity affected and type of formation found. Data on subsequent persistent irregular menstrual bleeding and pregnancy success up to 12 months following treatment will also be collected.

Enrollment: 100 estimated patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female sex
• indication for operative hysteroscopy including one or more of the following:
• infertility,
• irregular bleeding,
• oligo-/amenorrhea,
• Asherman syndrome,
• G0-G3 fibroids,
• dysmorphic uterus.

Exclusion criteria

• ongoing pregnancy,
• genital cancer,
• pelvic inflammatory disease,
• excessive uterine bleeding.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Heparin solution

Active Comparator group

Description:

Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy.

Treatment:

Drug: Heparin solution

Anti-adhesion barrier gel

Active Comparator group

Description:

Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy.

Treatment:

Drug: Anti-adhesion barrier gel