Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery Prospective Multicentre Randomized Comparative Study
This study was addressed to patients having an immediate or differed pregnancy desire and
presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.
- The primary end point was the assessment of adhesion rate to the uterine surgical sites
during a laparoscopic second look performed 10 to 20 weeks post-surgery.
- The secondary end points were the assessment, throughout a 3 years follow-up period,
- pregnancy rate,
- adverse events related to adhesions,
- adnexal adhesions according to American Fertility Society score,
- abdomino-pelvic adhesions according to the modified American Fertility Society
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look
10 to 20 weeks post surgery
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)