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

Study 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.

Official Title
-----------------
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

Conditions
-----------------
First Trimester Abortion, Surgical Abortion, Miscarriage With Afibrinogenemia

Intervention / Treatment
-----------------
* Device: MateRegen® gel (BioRegen)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (Group A): NCH gel after USG-MVA<br>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)<br>* 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.<br>|
| No Intervention: Controlled group (Group B): No NCH gel after USG-MVA<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of IUA | To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups. | 8-12 weeks after MVA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score | 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 | 8-12 weeks after MVA | 
| Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score | 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 | 8-12 weeks after MVA | 
| Complications or side effects with the NCH gel. | To examine the rate of complications or side effects with the NCH gel. | 8-12 weeks after MVA | 
| Subsequent menstrual frequency | 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 | 8-12 weeks after MVA | 
| Subsequent reproductive outcome | To assess the rate of pregnancy in both groups of patients | 8-12 weeks after MVA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First Trimester Abortion, Surgical Abortion, Intrauterine adhesion, Hyaluronan gel, Protective Agents, Hyaluronic Acid, Manual vacuum aspiration, Miscarriage