Status:
RECRUITING
New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Health and Medical Research Fund
Conditions:
First Trimester Abortion
Surgical Abortion
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 ...
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 sh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05360186
Start Date
June 14 2022
End Date
May 15 2026
Last Update
August 13 2025
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong