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

Not Applicable

Completed

• Conditions: Intrauterine Adhesion

• Registration Number: NCT03353909
• Lead Sponsor: BioRegen Biomedical (CHangzhou) Co., Ltd

Brief Summary

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

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 Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Study First Submitted: 2017-10-10
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-23
• Last Update Submitted: 2017-11-23
• Study First Posted: 2017-11-27
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of intrauterine adhesion	3 months after dilatation and curettage	The number of women with intrauterine adhesion

Secondary Outcome Measures

Name	Time	Method
The adhesion scores of menstrual pattern	3 months after dilatation and curettage	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
Severity	3 months after dilatation and curettage	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).
The adhesion scores of extent of uterine cavity involved	3 months after dilatation and curettage	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
Cumulative adhesion score	3 months after dilatation and curettage	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
The adhesion scores of type of adhesion	3 months after dilatation and curettage	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