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

NCT02868437 | Unknown Phase 4

• 1 other identifier: ODural
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Placenta Retained; Uterine Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The characteristic of the intrauterine adhesions

  2 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

NO INTERVENTION

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

Interventions

intrauterine self-cross-linked hyaluronic acid gel DEVICE

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

Group 1

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has curettage for retained product after second trimester abortion

You may not qualify if:

• History of curettage or other intrauterine surgery
• History of post-abortion complication or infection

Sponsors & Collaborators

• Istanbul University: lead
• Bilar Medikal, Turkey: collaborator

Related Publications (2)

• 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.

  PMID: 24082042 RESULT

• 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.

  PMID: 15105384 RESULT

MeSH Terms

Conditions

Placenta, Retained; Uterine Diseases

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Study Officials

• Ozlem Dural, M.D.

  Istanbul University School Of Medicine, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sultan Can, M.D.

CONTACT

+90 212 4142000; sltncn89@gmail.com

Gamze Yilmaz, M.D.

CONTACT

+90 212 4142000; gmzylmz89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal Investigator

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 16, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08