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Hyaluronic Acid and Uterine Synechiae (HYFACO)

Primary Purpose

Uterine Synechiae After Scraping for Natural Miscarriage

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Gel
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uterine Synechiae After Scraping for Natural Miscarriage focused on measuring Uterine synechiae Scraping surgery Natural miscarriage

Eligibility Criteria

18 Years - 46 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Lariboisière - Service de Gynécologie-Obstétrique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gel +

Gel -

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.

Secondary Outcome Measures

Evaluation of the effect of the non-stick gel application on the post-surgical fertility 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.
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
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
Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).

Full Information

First Posted
September 22, 2014
Last Updated
July 31, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02248376
Brief Title
Hyaluronic Acid and Uterine Synechiae
Acronym
HYFACO
Official Title
Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 14, 2014 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
September 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Synechiae After Scraping for Natural Miscarriage
Keywords
Uterine synechiae Scraping surgery Natural miscarriage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gel +
Arm Type
Experimental
Arm Description
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.
Arm Title
Gel -
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
Description
Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.
Time Frame
6-8 weeks after scraping surgery
Secondary Outcome Measure Information:
Title
Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery.
Description
Evaluation using questionnaires asked by post, mail or phone at 6, 12, and 24 months after scraping surgery.
Time Frame
6, 12 and 24 months after scraping surgery
Title
Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
Description
Evaluation using questionnaires asked by post, mail or phone at 12 and 24 months after scraping surgery.
Time Frame
Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
Title
Evaluation of post-surgical synechiae stretch and severity
Description
Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
Time Frame
6-8 weeks after scraping surgery
Title
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
Description
Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
Time Frame
36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Benifla, MD-PhD
Organizational Affiliation
Assistance Publique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lariboisière - Service de Gynécologie-Obstétrique
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35667420
Citation
Sroussi J, Bourret A, Pourcelot AG, Thubert T, Lesavre M, Legendre G, Tuffet S, Rousseau A, Benifla JL; HYFACO group. Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study). Am J Obstet Gynecol. 2022 Oct;227(4):597.e1-597.e8. doi: 10.1016/j.ajog.2022.05.064. Epub 2022 Jun 3.
Results Reference
derived

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Hyaluronic Acid and Uterine Synechiae

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