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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy of A New Crosslinked Hyaluronan Gel in the Prevention of Postoperative Intrauterine Adhesion After Dilatation and Curettage in Women With Delayed Miscarriage: A Prospective, Randomized, Controlled Trial

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Device: new crosslinked hyaluronan gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula. | Device: new crosslinked hyaluronan gel<br>* At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.<br>* Other names: MateRegen Gel;|
| No Intervention: Control<br>At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intrauterine adhesion | The number of women with intrauterine adhesion | 3 months after dilatation and curettage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adhesion scores of extent of uterine cavity involved | Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (<1/3 cavity with adhesion), 2 points (1/3-2/3 cavity with adhesion) and 4 points (>2/3 cavity with adhesion), high values represent worse outcome | 3 months after dilatation and curettage | 
| The adhesion scores of type of adhesion | Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (filmy adhesion), 2 points (filmy & dense adhesion) and 4 points (dense adhesion), high values represent worse outcome | 3 months after dilatation and curettage | 
| The adhesion scores of menstrual pattern | Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 0 point (normal), 2 points (hypomenorrhea) and 4 points (amenorrhea), high values represent worse outcome | 3 months after dilatation and curettage | 
| Cumulative adhesion score | The summed score of the adhesion scores of extent of uterine cavity involved, type of adhesion and menstrual pattern; range: 1-12 points, high values represent worse outcome | 3 months after dilatation and curettage | 
| Severity | Graded according to cumulative adhesion score: Stage I (mild)(1-4 points), Stage II (moderate)(5-8 points) and Stage III (severe)(9-12 points). | 3 months after dilatation and curettage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine adhesion, Delayed miscarriage, hyaluronan gel