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

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

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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Adhesion
• Intervention / Treatment: Device: new crosslinked hyaluronan gel

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: new crosslinked hyaluronan gel; At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.; Other Names: MateRegen Gel
No Intervention: Control; At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intrauterine adhesion	The number of women with intrauterine adhesion	3 months after dilatation and curettage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: BioRegen Biomedical (CHangzhou) Co., Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 15, 2017

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Intrauterine adhesion; Delayed miscarriage; hyaluronan gel
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: FNL-2016-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No