New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT

February 21, 2023 updated by: Chung Pui Wah Jacqueline, Chinese University of Hong Kong

The Efficacy and Safety of a New Cross-linked Hyaluronan Gel to Prevent Adhesion After Ultrasound-guided Manual Vacuum Aspiration (USG-MVA): A Prospective Randomized Controlled Trial

The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage.

  • To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients.
  • To examine the rate of complications or side effects with the NCH gel.
  • To assess the subsequent menstrual history and reproductive outcome in both groups of patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There is limited data to evaluate the incidence of IUA after using this NCH gel in patients undergoing surgical evacuation via USG-MVA for the treatment of first-trimester miscarriage. Previous RCT showed a significant reduction in IUA with the use of NCH gel, with IUA detected in only 9.5% of patients with NCH gel applied compared to 24.1% in the control group. However, the group did not involve patients undergoing surgical evacuation by USG-MVA.

Therefore, the objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment of first-trimester miscarriage.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
        • Contact:
        • Sub-Investigator:
          • KAREN NG, MBBS
        • Principal Investigator:
          • Oui Wah Jacqueline CHUNG, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18 years old or above
  • No previous history of IUA/ Asherman's syndrome
  • No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
  • No previous history of therapeutic hysteroscopic surgeries
  • Voluntary informed consent and understanding of study

Exclusion Criteria:

  • previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
  • suspicion of molar pregnancy
  • genital tract malformation
  • suspicion of active infection or genital tract malignancy or genital tuberculosis
  • abnormal blood coagulation
  • inability to tolerate pelvic examination known
  • suspected intolerance of hypersensitivity to NCH gel or its derivatives
  • patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (Group A): NCH gel after USG-MVA
In the intervention group (Group A), a 15 cm sterile delivery cannula will be inserted through the internal os and a syringe of NCH gel (5ml) will be applied to the uterine cavity after cleansing the cervix with an antiseptic solution.
Device: MateRegen® gel (BioRegen)
Modification of Hyaluronic acid structure to 3-dimensional self-cross-linked network structure enables all-dimensional coverage of tissue surface to enhance better healing process. Self-cross-linked HA hydrogels can maintain the biocompatibility and biodegradability that characterize the unmodified material. Moreover, high dynamic viscosity enables continuous indwelling in the uterine cavity. The gel could provide precise regulation, and degradation and absorption time prolonged to 7-14 days post operatively, which completely cover key postoperative healing period (5-7 days), at the highest time of intrauterine adhesion formation.
No Intervention: Controlled group (Group B): No NCH gel after USG-MVA
In the control group (Group B), as the patient is conscious during the procedure, an empty 5ml syringe will be inserted into the internal os and held for 1 minute as a sham procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of IUA
Time Frame: 8-12 weeks after MVA
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.
8-12 weeks after MVA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
Time Frame: 8-12 weeks after MVA

To study the severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score in both groups of patients.

The American Fertility Society's (AFS) classification of intrauterine adhesions:

Stage I (mild) with score 1-4, Stage II (moderate) with score 5-8, Stage III (severe) with score 9-12
8-12 weeks after MVA
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
Time Frame: 8-12 weeks after MVA
To study the severity and extent of the intrauterine adhesions as assessed by the European Society of Gynaecological Endoscopy (ESGE) adhesion score in both groups of patients. It includes grades I and II as mild adhesion, grade III as moderate adhesion, grades IV and V as severe adhesion
8-12 weeks after MVA
Complications or side effects with the NCH gel.
Time Frame: 8-12 weeks after MVA
To examine the rate of complications or side effects with the NCH gel.
8-12 weeks after MVA
Subsequent menstrual frequency
Time Frame: 8-12 weeks after MVA
To assess the subsequent menstrual frequency in both groups of patients. Frequency - average 28 days <24 days Frequent, >38 days Infrequent Frequency - average 28 days <24 days Frequent, >38 days Infrequent
8-12 weeks after MVA
Subsequent reproductive outcome
Time Frame: 8-12 weeks after MVA
To assess the rate of pregnancy in both groups of patients
8-12 weeks after MVA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Health and Medical Research Fund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Anticipated)

May 14, 2025

Study Completion (Anticipated)

May 15, 2026

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021.702-T

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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