Clinical Trial: Hyaluronic Acid and Uterine Synechiae

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention

Brief Summary:

The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery.

Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.

Detailed Summary:

Women patients coming for natural miscarriage will be compared according to whether a non-stick gel will be applicated or not after scraping surgery.

6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study without knowing the randomization arm.

Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery using questionnaire asked by post, mail or phone.

Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy. [ Time Frame: 6-8 weeks after scraping surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery. [ Time Frame: 6, 12 and 24 months after scraping surgery ]
  Evaluation using questionnaires asked by post, mail or phone at 6, 12, and 24 months after scraping surgery.
• Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery. [ Time Frame: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery. ]
  Evaluation using questionnaires asked by post, mail or phone at 12 and 24 months after scraping surgery.
• Evaluation of post-surgical synechiae stretch and severity [ Time Frame: 6-8 weeks after scraping surgery ]
  Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
• Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study [ Time Frame: 36 months ]
  Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).

Original Secondary Outcome:

• Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery. [ Time Frame: 6, 12 and 24 months after scraping surgery ]
  Evaluation using questionnaires asked by post, mail or phone at 6, 12, and 24 months after scraping surgery.
• Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery. [ Time Frame: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery. ]
  Evaluation using questionnaires asked by post, mail or phone at 12 and 24 months after scraping surgery.
• Evaluation of post-surgical synechiae stretch and severity [ Time Frame: 6-8 weeks after scraping surgery ]
  Synechiae stetch and severity will be evaluated by the American Fertility Society classification (rAFS).
• Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study [ Time Frame: 36 months ]
  Synechiae stetch and severity will be evaluated by the American Fertility Society classification (rAFS).

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 22, 2014
Date Started: November 2014
Date Completion: May 2018
Last Updated: March 24, 2017
Last Verified: March 2017