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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 300
- Primary Endpoint
- Incidence of intrauterine adhesion
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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.
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.
Arms & Interventions
Control
At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.
Treatment
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.
Intervention: new crosslinked hyaluronan gel (Device)
Outcomes
Primary Outcomes
Incidence of intrauterine adhesion
Time Frame: 3 months after dilatation and curettage
The number of women with intrauterine adhesion
Secondary Outcomes
- The adhesion scores of menstrual pattern(3 months after dilatation and curettage)
- Severity(3 months after dilatation and curettage)
- The adhesion scores of extent of uterine cavity involved(3 months after dilatation and curettage)
- Cumulative adhesion score(3 months after dilatation and curettage)
- The adhesion scores of type of adhesion(3 months after dilatation and curettage)