Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to test the benefit of using gamma-irradiated amniotic membrane as a graft in surgical repair for women with posterior vaginal wall defects. The main question it aims to answer is: • Is posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft effective? Participants will undergo posterior colporrhaphy, which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: f
View:
• Women diagnosed as posterior vaginal wall prolapse: bulging of front wall of rectum into the vagina due to weakening of pelvic support system and thinning of rectovaginal septum.
• Women aged 30-60 years.
• BMI 20-35 kg/m2
• Planned for surgical correction
Locations
Other Locations
Egypt
Ain Shams Maternity Hospital
RECRUITING
Cairo
Contact Information
Primary
Rania HM Ahmed, MD
raneyah@med.asu.edu.eg
01200522444
Backup
Nourhan A El-Sherbiny, MSc
nourhan.elsherbiny93@gmail.com
01006782554
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 25
Treatments
Experimental: amniotic membrane graft
women with posterior vaginal prolapse will be enrolled and posterior colporrhaphy will be done with the application of sterilized (gamma irradiated) amniotic membrane as a graft.
Related Therapeutic Areas
Sponsors
Leads: Ain Shams Maternity Hospital