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Hyaluronic Acid and Uterine Synechiae (HYFACO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248376
Recruitment Status : Unknown
Verified July 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Uterine Synechiae After Scraping for Natural Miscarriage Drug: Gel Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention
Study Start Date : November 2014
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arm Intervention/treatment
Experimental: Gel +
Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.
Drug: Gel
Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.

No Intervention: Gel -
Patients aged of more than 18 years-old coming for a natural miscarriage who will not have the non-stick gel application at the end of the scraping surgery.



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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women patients aged between 18 and 46 years old
  • Term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea
  • Blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention miscarriage
  • Consent signature
  • Social security coverage
  • Women who wants to be pregnant

Exclusion Criteria:

  • Infected miscarriage
  • Uncertain diagnosis between miscarriage and extra-uterine pregnancy
  • Hydatiform mole
  • Uterine synechiae history
  • Surgical zone infection
  • Hyalobarrier® gel Endo hypersensitivity
  • Clotting disorder
  • Unstable diabetes
  • Maternal malignant diseases
  • Psychiatric disorder
  • Incapacity in understanding the consent form and the questionnaires
  • Law protected adult person

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248376


Locations
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France
Hôpital Lariboisière - Service de Gynécologie-Obstétrique
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Louis Benifla, MD-PhD Assistance Publique
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02248376    
Other Study ID Numbers: P 130911
AOR13019 ( Other Identifier: Assistance Publique )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: July 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Uterine synechiae Scraping surgery Natural miscarriage
Additional relevant MeSH terms:
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Abortion, Spontaneous
Gynatresia
Pregnancy Complications