Clinical trial NCT03353909: The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: Intrauterine adhesion
Delayed miscarriage
hyaluronan gel
Lead sponsor: BioRegen Biomedical (CHangzhou) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-11-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of intrauterine adhesion
timeFrame: 3 months after dilatation and curettage
Secondary outcomes:
measure: The adhesion scores of extent of uterine cavity involved
timeFrame: 3 months after dilatation and curettage
measure: The adhesion scores of type of adhesion
timeFrame: 3 months after dilatation and curettage
measure: The adhesion scores of menstrual pattern
timeFrame: 3 months after dilatation and curettage
measure: Cumulative adhesion score
timeFrame: 3 months after dilatation and curettage
measure: Severity
timeFrame: 3 months after dilatation and curettage
Other outcomes:
Locations:
Study officials:
References:
citation: Li X, Wu L, Zhou Y, Fan X, Huang J, Wu J, Yu R, Lou J, Yang M, Yao Z, Xue M. New Crosslinked Hyaluronan Gel for the Prevention of Intrauterine Adhesions after Dilation and Curettage in Patients with Delayed Miscarriage: A Prospective, Multicenter, Randomized, Controlled Trial. J Minim Invasive Gynecol. 2019 Jan;26(1):94-99. doi: 10.1016/j.jmig.2018.03.032. Epub 2018 Apr 17.