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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
Recruiting
Hong Kong
Contact Information
Primary
Elaine NG
elaineng@cuhk.edu.hk
35052745
Backup
Stacey Wong, Bsc
staceywong@cuhk.edu.hk
35051764
Time Frame
Start Date: June 14, 2022
Estimated Completion Date: May 15, 2026
Participants
Target number of participants: 150
Treatments
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.
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.
Authors
Sponsors
Leads: Chinese University of Hong Kong
Collaborators: Health and Medical Research Fund

This content was sourced from clinicaltrials.gov

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