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Recruiting NCT05360186

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

Trial Parameters

Condition First Trimester Abortion
Sponsor Chinese University of Hong Kong
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2022-06-14
Completion 2026-05-14
Interventions
MateRegen® gel (BioRegen)

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.

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

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