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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- First Trimester Abortion
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Incidence of IUA
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong
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
Outcomes
Primary Outcomes
Incidence of IUA
Time Frame: 8-12 weeks after MVA
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.
Secondary Outcomes
- Subsequent reproductive outcome(8-12 weeks after MVA)
- 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)