Hyaluronic Acid and Uterine Synechiae (HYFACO)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Uterine Synechiae After Scraping for Natural Miscarriage

Treatments: Drug: Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02248376

AOR13019 (Other Identifier)

P 130911

Details and patient eligibility

About

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.

Full 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.

Enrollment: 364 patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 2 patient groups

Gel +

Experimental group

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.

Treatment:

Drug: Gel

Gel -

No Intervention group

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.