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
Chinese University of Hong Kong
150 participants
Jun 14, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria8
- 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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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.
Locations(1)
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NCT05360186