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

Phase 4

• Conditions: Placenta Retained; Uterine Diseases
• Interventions: Device: intrauterine self-cross-linked hyaluronic acid gel

• Registration Number: NCT02868437
• Lead Sponsor: Istanbul University

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 Description

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.

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-14
• Last Update Submitted: 2016-08-14
• Study First Posted: 2016-08-16
• Last Update Posted: 2016-08-16
• Study Start: 2016-09
• Primary Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Subject has curettage for retained product after second trimester abortion

Exclusion Criteria

• History of curettage or other intrauterine surgery
• History of post-abortion complication or infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	intrauterine self-cross-linked hyaluronic acid gel	The patients who are having curettage for retained product after second trimester abortion will also receive an intervention of intrauterine self-cross-linked hyaluronic acid gel after the procedure

Primary Outcome Measures

Name	Time	Method
The presence of de-novo post-curettage adhesions	2 months	In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion

Secondary Outcome Measures

Name	Time	Method
The characteristic of the intrauterine adhesions	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