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

Primary Purpose

First Trimester Abortion, Surgical Abortion, Miscarriage With Afibrinogenemia

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
MateRegen® gel (BioRegen)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for First Trimester Abortion focused on measuring First Trimester Abortion, Surgical Abortion, Intrauterine adhesion, Hyaluronan gel, Protective Agents, Hyaluronic Acid, Manual vacuum aspiration, Miscarriage

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group (Group A): NCH gel after USG-MVA

Controlled group (Group B): No NCH gel after USG-MVA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of IUA
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.

Secondary Outcome Measures

Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
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
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
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
Complications or side effects with the NCH gel.
To examine the rate of complications or side effects with the NCH gel.
Subsequent menstrual frequency
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
Subsequent reproductive outcome
To assess the rate of pregnancy in both groups of patients

Full Information

First Posted
March 31, 2022
Last Updated
February 21, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Health and Medical Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05360186
Brief Title
New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
May 14, 2025 (Anticipated)
Study Completion Date
May 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Health and Medical Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Trimester Abortion, Surgical Abortion, Miscarriage With Afibrinogenemia
Keywords
First Trimester Abortion, Surgical Abortion, Intrauterine adhesion, Hyaluronan gel, Protective Agents, Hyaluronic Acid, Manual vacuum aspiration, Miscarriage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (Group A): NCH gel after USG-MVA
Arm Type
Experimental
Arm Description
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.
Arm Title
Controlled group (Group B): No NCH gel after USG-MVA
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MateRegen® gel (BioRegen)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of IUA
Description
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.
Time Frame
8-12 weeks after MVA
Secondary Outcome Measure Information:
Title
Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
Description
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
Time Frame
8-12 weeks after MVA
Title
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
Description
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
Time Frame
8-12 weeks after MVA
Title
Complications or side effects with the NCH gel.
Description
To examine the rate of complications or side effects with the NCH gel.
Time Frame
8-12 weeks after MVA
Title
Subsequent menstrual frequency
Description
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
Time Frame
8-12 weeks after MVA
Title
Subsequent reproductive outcome
Description
To assess the rate of pregnancy in both groups of patients
Time Frame
8-12 weeks after MVA

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine NG
Phone
35052745
Email
elaineng@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Wong, Bsc
Phone
35051764
Email
staceywong@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PUI WAH JACQUELINE CHUNG, MBBS
Phone
+852 35051537
Email
jacquelinechung@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Stacey Wong, Bsc
Phone
+852-35051764
Email
staceywong@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Oui Wah Jacqueline CHUNG, MBBS
First Name & Middle Initial & Last Name & Degree
Karen NG, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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