Image

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

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

Recruiting
18-50 years
Female
Phase N/A

Powered by AI

Overview

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.

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

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

Study details
    First Trimester Abortion
    Surgical Abortion
    Miscarriage With Afibrinogenemia

NCT05360186

Chinese University of Hong Kong

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.