New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
Study Details
Study Description
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.
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To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients.
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To examine the rate of complications or side effects with the NCH gel.
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To assess the subsequent menstrual history and reproductive outcome in both groups of patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group (Group A): NCH gel after USG-MVA In 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. |
Device: MateRegen® gel (BioRegen)
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.
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| No Intervention: Controlled group (Group B): No NCH gel after USG-MVA In 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. |
Outcome Measures
Primary Outcome Measures
- Incidence of IUA [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 Outcome Measures
- Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score [8-12 weeks after MVA]
To study the severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score in both groups of patients. The American Fertility Society's (AFS) classification of intrauterine adhesions: Stage I (mild) with score 1-4, Stage II (moderate) with score 5-8, Stage III (severe) with score 9-12
- Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score [8-12 weeks after MVA]
To study the severity and extent of the intrauterine adhesions as assessed by the European Society of Gynaecological Endoscopy (ESGE) adhesion score in both groups of patients. It includes grades I and II as mild adhesion, grade III as moderate adhesion, grades IV and V as severe adhesion
- Complications or side effects with the NCH gel. [8-12 weeks after MVA]
To examine the rate of complications or side effects with the NCH gel.
- Subsequent menstrual frequency [8-12 weeks after MVA]
To assess the subsequent menstrual frequency in both groups of patients. Frequency - average 28 days <24 days Frequent, >38 days Infrequent Frequency - average 28 days <24 days Frequent, >38 days Infrequent
- Subsequent reproductive outcome [8-12 weeks after MVA]
To assess the rate of pregnancy in both groups of patients
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women 18 years old or above
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No previous history of IUA/ Asherman's syndrome
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No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
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No previous history of therapeutic hysteroscopic surgeries
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Voluntary informed consent and understanding of study
Exclusion Criteria:
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previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
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suspicion of molar pregnancy
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genital tract malformation
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suspicion of active infection or genital tract malignancy or genital tuberculosis
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abnormal blood coagulation
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inability to tolerate pelvic examination known
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suspected intolerance of hypersensitivity to NCH gel or its derivatives
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patient refusal
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chinese University of Hong Kong
- Health and Medical Research Fund
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021.702-T