Placenta Retained, Uterine Diseases
Conditions
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.
Interventions
DEVICEintrauterine self-cross-linked hyaluronic acid gel
intrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion
Sponsors
Bilar Medikal, Turkey
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence of de-novo post-curettage adhesions | 2 months | In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The characteristic of the intrauterine adhesions | 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 |
Contacts
Primary ContactSultan Can, M.D.
Backup ContactGamze Yilmaz, M.D.
Outcome results
None listed