Pregnant women who undergo scheduled cesarean section Cesarean section Intraoperative care Hyaluronan
Conditions
Interventions
The investigational group will receive an absorbable adhesion barrier gel of 10 ml, which will be applied around the hysterotomy area following the standard cesarean section.,The investigational group
absorbable adhesion barrier gel: cross-linked hyaluronan gel,Standard hysterotomy closure
Sponsors
Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Pregnant women who are scheduled for term cesarean section with no restrictions on parity 2.No severe pregnancy complications or comorbidities 3.No history of pelvic or abdominal surgery or infection 4.Willingness to participate in the study, comply with the study requirements and follow-up schedule, and sign a written informed consent before any study-related procedures
Exclusion criteria
Exclusion criteria: 1.Known severe allergy to hyaluronic acid or its derivatives 2.History of severe systemic diseases 3.History of bowel perforation or mechanical bowel obstruction 4.Planned use of any anti-adhesion material other than HyaRegen Gel during surgery. 5.Expected to undergo additional surgeries (e.g., ovarian cystectomy, myomectomy) during cesarean section 6.Presence of moderate to severe abdominal adhesions or severe contamination during cesarean section 7.Undergoing B lynch suture or uterine artery embolization during cesarean section 8.History of severe endometriosis 9.Investigators believe that impaired immune system function or coagulation disorders may affect wound healing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uteropelvic adhesion postpartum 6 weeks Negative ultrasound sliding sign by transvaginal ultrasound | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic pelvic pain Post operation 6 weeks visual analog scale (0-10),Abnormal bowel-bladder symptoms Postpartum 6 weeks Present/ Absent,Clinical adhesion score Post operation 6 weeks scale 0-4 (pain, bowel, bladder, sexual activity),Time to flatus Immediate post-operation Hour,Time to start ambulation Immediate post-operation Hour,Post operative fever Immediate post-operation Present/ ABsent,Length of hospital stay Immediate post-operation Day,Abnormal bowel-bladder symptoms Immediate post-operation Present/ Absent,Urinary retention required additional retained foley catheter Immediate post-operation Present/ Absent,Surgical scar formation Postpartum 6 weeks Physical examination categorized scar to Flatted, Depressed, Elevated, or Mixed type,Abnormal vaginal discharge Postpartum 6 weeks Present/ Absent on a speculum vaginal examination,Pelvic fluid collection Postpartum 6 weeks Present/ Absent on routine transvaginal ultrasound,Hyperechoic band at vesicouterine fold Postpartum 6 weeks Present/ Absent on routine transvaginal ultrasound | — |
Countries
Thailand
Contacts
Public ContactSanpon Diawtipsukon
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed