Hyaluronic Acid and Uterine Synechiae (HYFACO)

July 31, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

364

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Lariboisière - Service de Gynécologie-Obstétrique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-8 weeks after scraping surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 the obstetric complication rate 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).
6-8 weeks after scraping surgery
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).
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean-Louis Benifla, MD-PhD, Assistance Publique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2014

Primary Completion (Actual)

September 14, 2018

Study Completion (Actual)

September 14, 2018

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 31, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 130911
  • AOR13019 (Other Identifier: Assistance Publique)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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