Intrauterine Adhesion
Conditions
Keywords
Intrauterine adhesion, Delayed miscarriage, hyaluronan gel
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.
Interventions
DEVICEnew crosslinked hyaluronan gel
At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
Sponsors
BioRegen Biomedical (CHangzhou) Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intrauterine adhesion | 3 months after dilatation and curettage | The number of women with intrauterine adhesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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). |
Outcome results
None listed