Clinical Trial: Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effectiveness of Self-cross-linked Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion

Brief Summary: This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following curettage for retained product after second trimester abortion. One group of participants will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid gel while the other group will underwent curettage alone (control group).

Detailed Summary:

Intrauterine adhesions are the major long‐term complication of curettage for retained products of conception. The risk of adhesion is higher after second trimester abortion. This complication may result in infertility, recurrent miscarriages and irregular periods with dysmenorrhea and pelvic pain.

They have been reported that the intrauterine application of auto‐crosslinked hyaluronic acid gel following hysteroscopic adhesiolysis or hysteroscopic surgery significantly reduces the formation of post‐operative intrauterine adhesions.

The aim of this prospective, randomized, controlled study is to evaluate the efficacy of self-crosslinked hyaluronic acid gel in the reduction of development of de‐novo post‐curettage adhesions at 2 months follow‐up.


Sponsor: Istanbul University

Current Primary Outcome: The presence of de‐novo post‐curettage adhesions [ Time Frame: 2 months ]

In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion


Original Primary Outcome: Same as current

Current Secondary Outcome: The characteristic of the intrauterine adhesions [ Time Frame: 2 months ]

If any intrauterine adhesion is detected during the Hysteroscopy, American Fertility Society/American Society for Reproductive Medicine classification of intrauterine adhesions will be used to describe to the characteristic of the intrauterine adhesions


Original Secondary Outcome: Same as current

Information By: Istanbul University

Dates:
Date Received: August 10, 2016
Date Started: September 2016
Date Completion:
Last Updated: August 14, 2016
Last Verified: August 2016