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

Intrauterine Adhesion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353909
• Other study ID #: FNL-2016-03
• Status: Completed
• Phase: N/A
• First received: October 10, 2017
• Last updated: November 23, 2017
• Start date: July 1, 2016
• Est. completion date: February 15, 2017

Study information

• Verified date: November 2017
• Source: BioRegen Biomedical (CHangzhou) Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• new crosslinked hyaluronan gel
At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioRegen Biomedical (CHangzhou) Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intrauterine adhesion	The number of women with intrauterine adhesion	3 months after dilatation and curettage
Secondary	The adhesion scores of extent of uterine cavity involved	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	3 months after dilatation and curettage
Secondary	The adhesion scores of type of adhesion	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	3 months after dilatation and curettage
Secondary	The adhesion scores of menstrual pattern	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	3 months after dilatation and curettage
Secondary	Cumulative adhesion score	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	3 months after dilatation and curettage
Secondary	Severity	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).	3 months after dilatation and curettage