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

NCT ID: NCT02868437

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Placenta Retained Uterine Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

intrauterine self-cross-linked hyaluronic acid gel

Intervention Type DEVICE

intrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion

Group 2

The patients who are having curettage for retained product after second trimester abortion will receive no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bilar Medikal, Turkey

UNKNOWN

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Dural

M.D., Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ozlem Dural, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University School Of Medicine, Department of Obstetrics and Gynecology

Central Contacts

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Sultan Can, M.D.

Role: CONTACT

+90 212 4142000 ext. 31687

Gamze Yilmaz, M.D.

Role: CONTACT

+90 212 4142000

References

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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.

Reference Type RESULT
PMID: 24082042 (View on PubMed)

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.

Reference Type RESULT
PMID: 15105384 (View on PubMed)

Other Identifiers

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ODural

Identifier Type: -

Identifier Source: org_study_id

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