Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
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|ClinicalTrials.gov Identifier: NCT02868437|
Recruitment Status : Unknown
Verified August 2016 by Ozlem Dural, Istanbul University.
Recruitment status was: Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Placenta Retained Uterine Diseases||Device: intrauterine self-cross-linked hyaluronic acid gel||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Self-cross-linked Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 2017|
Active Comparator: Group 1
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
Device: intrauterine self-cross-linked hyaluronic acid gel
intrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion
No Intervention: Group 2
The patients who are having curettage for retained product after second trimester abortion will receive no intervention
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868437
|Contact: Sultan Can, M.D.||+90 212 4142000 ext firstname.lastname@example.org|
|Contact: Gamze Yilmaz, M.D.||+90 212 email@example.com|
|Principal Investigator:||Ozlem Dural, M.D.||Istanbul University School Of Medicine, Department of Obstetrics and Gynecology|