Clinical trial NCT02248376: Hyaluronic Acid and Uterine Synechiae
Official title: Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Synechiae After Scraping for Natural Miscarriage
Keywords: Uterine synechiae Scraping surgery Natural miscarriage
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
timeFrame: 6-8 weeks after scraping surgery
Secondary outcomes:
measure: Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery.
timeFrame: 6, 12 and 24 months after scraping surgery
measure: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
timeFrame: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
measure: Evaluation of post-surgical synechiae stretch and severity
timeFrame: 6-8 weeks after scraping surgery
measure: 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
timeFrame: 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière - Service de Gynécologie-Obstétrique
Study officials:
affiliation: Assistance Publique
name: Jean-Louis Benifla, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.