New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedStudy Start
First participant enrolled
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2026
August 13, 2025
August 1, 2025
3.9 years
March 31, 2022
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8-12 weeks after MVA
Secondary Outcomes (5)
Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
8-12 weeks after MVA
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
8-12 weeks after MVA
Complications or side effects with the NCH gel.
8-12 weeks after MVA
Subsequent menstrual frequency
8-12 weeks after MVA
Subsequent reproductive outcome
8-12 weeks after MVA
Study Arms (2)
Intervention group (Group A): NCH gel after USG-MVA
EXPERIMENTALIn 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.
Controlled group (Group B): No NCH gel after USG-MVA
NO INTERVENTIONIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese University of Hong Konglead
- Health and Medical Research Fundcollaborator
Study Sites (1)
The Chinese University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 31, 2022
First Posted
May 4, 2022
Study Start
June 14, 2022
Primary Completion (Estimated)
May 14, 2026
Study Completion (Estimated)
May 15, 2026
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share