Clinical trial NCT05360186: New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: First Trimester Abortion
Surgical Abortion
Miscarriage With Afibrinogenemia
Keywords: First Trimester Abortion
Surgical Abortion
Intrauterine adhesion
Hyaluronan gel
Protective Agents
Hyaluronic Acid
Manual vacuum aspiration
Miscarriage
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2022-05-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of IUA
timeFrame: 8-12 weeks after MVA
Secondary outcomes:
measure: Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
timeFrame: 8-12 weeks after MVA
measure: Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
timeFrame: 8-12 weeks after MVA
measure: Complications or side effects with the NCH gel.
timeFrame: 8-12 weeks after MVA
measure: Subsequent menstrual frequency
timeFrame: 8-12 weeks after MVA
measure: Subsequent reproductive outcome
timeFrame: 8-12 weeks after MVA
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: