Hyaluronic Acid and Uterine Synechiae

Uterine Synechiae After Scraping for Natural Miscarriage Clinical Trial

— HYFACO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248376
• Other study ID #: P 130911
• Secondary ID: AOR13019
• Status: Completed
• Phase: Phase 3
• Start date: November 14, 2014
• Est. completion date: September 14, 2018

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Uterine Synechiae After Scraping for Natural Miscarriage

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Lariboisière - Service de Gynécologie-Obstétrique	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.	Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.	6-8 weeks after scraping surgery
Secondary	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.	6, 12 and 24 months after scraping surgery
Secondary	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.
Secondary	Evaluation of post-surgical synechiae stretch and severity	Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).	6-8 weeks after scraping surgery
Secondary	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).	36 months