The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
- Conditions
- Intrauterine Adhesion
- Interventions
- Device: new crosslinked hyaluronan gel
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment new crosslinked hyaluronan gel 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.
- 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