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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
Sponsor:
Collaborator:
Bilar Medikal, Turkey
Information provided by (Responsible Party):
Ozlem Dural, 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).

Condition or disease Intervention/treatment Phase
Placenta Retained Uterine Diseases Device: intrauterine self-cross-linked hyaluronic acid gel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Sultan Can, M.D. +90 212 4142000 ext 31687 sltncn89@gmail.com
Contact: Gamze Yilmaz, M.D. +90 212 4142000 gmzylmz89@gmail.com

Sponsors and Collaborators
Istanbul University
Bilar Medikal, Turkey
Investigators
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Principal Investigator: Ozlem Dural, M.D. Istanbul University School Of Medicine, Department of Obstetrics and Gynecology
Publications of Results:
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Responsible Party: Ozlem Dural, M.D., Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT02868437    
Other Study ID Numbers: ODural
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Uterine Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents