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NCT02868437 Clinical Trial

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

Uterine Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02868437
Other study ID # ODural
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 10, 2016
Last updated August 14, 2016
Start date September 2016

Study information
Verified date August 2016
Source Istanbul University
Contact Sultan Can, M.D.
Phone +90 212 4142000
Email sltncn89@gmail.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Istanbul University Bilar Medikal, Turkey

References & Publications (2)

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, randomiz — View Citation

Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brölmann 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 months No
Secondary 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 2 months No
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