The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion

BioRegen Biomedical (CHangzhou) Co., Ltd300 enrolled

Overview

Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.

Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage. Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage. Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation. Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

300

Conditions

Intrauterine Adhesion

Interventions

new crosslinked hyaluronan gelDEVICE

At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

The inclusion criteria: * Patients to be female, aged 18-45 years * Without previous dilatation and curettage * Undergoing dilatation and curettage for the current delayed miscarriage * All participants should be with normal liver/rental function and without systemic disease * Agree to use adequate forms of contraception throughout the study * Be in good compliance with the follow-up examination according to the study protocol. The exclusion criteria: * Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives * Genital tract malformation * Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract * Suspected genital tuberculosis * Abnormal blood coagulation * Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness * Acute or severe infection * Autoimmune diseases.