Clinical Trials Directory

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UnknownNCT02868437

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

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Istanbul University · Academic / Other
Sex
Female
Age
18 Years – 39 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEintrauterine self-cross-linked hyaluronic acid gelintrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion

Timeline

Start date
2016-09-01
Primary completion
2017-01-01
First posted
2016-08-16
Last updated
2016-08-16

Source: ClinicalTrials.gov record NCT02868437. Inclusion in this directory is not an endorsement.