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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Surgical Abortion; Miscarriage With Afibrinogenemia; First Trimester Abortion

Treatments: Device: MateRegen® gel (BioRegen)

Study type: Interventional

Funder types: Other

Identifiers

NCT05360186

2021.702-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Intervention group (Group A): NCH gel after USG-MVA

Experimental group

Description:

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.

Treatment:

Device: MateRegen® gel (BioRegen)

Controlled group (Group B): No NCH gel after USG-MVA

No Intervention group

Description:

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.