Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
Primary Purpose
Placenta Retained, Uterine Diseases
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
intrauterine self-cross-linked hyaluronic acid gel
Sponsored by
About this trial
This is an interventional prevention trial for Placenta Retained
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group 1
Group 2
Arm Description
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
The patients who are having curettage for retained product after second trimester abortion will receive no intervention
Outcomes
Primary Outcome Measures
The presence of de-novo post-curettage adhesions
In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion
Secondary Outcome Measures
The characteristic of the intrauterine adhesions
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
Full Information
NCT ID
NCT02868437
First Posted
August 10, 2016
Last Updated
August 14, 2016
Sponsor
Istanbul University
Collaborators
Bilar Medikal, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT02868437
Brief Title
Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
Official Title
Effectiveness of Self-cross-linked Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Bilar Medikal, Turkey
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Retained, Uterine Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
The patients who are having curettage for retained product after second trimester abortion will receive no intervention
Intervention Type
Device
Intervention Name(s)
intrauterine self-cross-linked hyaluronic acid gel
Intervention Description
intrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion
Primary Outcome Measure Information:
Title
The presence of de-novo post-curettage adhesions
Description
In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion
Time Frame
2 months
Secondary Outcome Measure Information:
Title
The characteristic of the intrauterine adhesions
Description
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
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sultan Can, M.D.
Phone
+90 212 4142000
Ext
31687
Email
sltncn89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze Yilmaz, M.D.
Phone
+90 212 4142000
Email
gmzylmz89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Dural, M.D.
Organizational Affiliation
Istanbul University School Of Medicine, Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24082042
Citation
Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29.
Results Reference
result
PubMed Identifier
15105384
Citation
Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
Results Reference
result
Learn more about this trial
Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
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