Completed

NCT Number: NCT02248376

Hyaluronic Acid and Uterine Synechiae

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.

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Key information

Conditions

Uterine Synechiae After Scraping for Natural Miscarriage

Age range

18 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Lariboisière - Service de Gynécologie-Obstétrique

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gel

Drug

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 outcomes

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.

Secondary outcomes

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.
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 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).
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).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: HYFACO

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Sep 25, 2014
Registry last updated: Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.