Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:24 AM
Study NCT ID:
NCT07474194
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
Sponsor:
Beni-Suef University
Organization:
Study Overview
Official Title:
Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSI
Brief Summary:
To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.
Detailed Description:
All patients (interventions and control group) are informed not to practice coitus, or use any vaginal products (such as douches, tampons or any type of pessary) during the period of intervention. Also, no vaginal examination was performed to all participants within 3 days of the CS.
The circulating nurse will clean the skin to all participants by following the manufacturer's guidelines.
The antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin.
The skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances.
All the enrolled participants receive the same health education and wound care advice from the professional health team.
All participants will be given spinal anesthesia. Patients are catheterized with Foley's catheter no 16 F under complete aseptic conditions then abdominal scrub is performed as usual using povidone iodine. Pfannenstiel incision is performed as usual.
Transverse incision is performed in the lower uterine segment followed by delivery of the baby and the placenta and membrane.
Antibiotics are given according to hospital protocol (ceftriaxone 1gm and metronidazole iv /12 hours in first 24 hours starting within 1 hour from skin incision ) followed by Amoxicillin -clavulanic acid for 5 days after discharge Follow up after cesarean section
* All patients receive routine postoperative care without further interventions.
* All patients are advised to return to hospital if they develop symptoms of infections such as hotness of the body, foul smelling vaginal discharge, persistent/increasing lower abdominal pain, wound discharge, swelling, redness, or dehiscence
The circulating nurse will clean the skin to all participants by following the manufacturer's guidelines.
The antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin.
The skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances.
All the enrolled participants receive the same health education and wound care advice from the professional health team.
All participants will be given spinal anesthesia. Patients are catheterized with Foley's catheter no 16 F under complete aseptic conditions then abdominal scrub is performed as usual using povidone iodine. Pfannenstiel incision is performed as usual.
Transverse incision is performed in the lower uterine segment followed by delivery of the baby and the placenta and membrane.
Antibiotics are given according to hospital protocol (ceftriaxone 1gm and metronidazole iv /12 hours in first 24 hours starting within 1 hour from skin incision ) followed by Amoxicillin -clavulanic acid for 5 days after discharge Follow up after cesarean section
* All patients receive routine postoperative care without further interventions.
* All patients are advised to return to hospital if they develop symptoms of infections such as hotness of the body, foul smelling vaginal discharge, persistent/increasing lower abdominal pain, wound discharge, swelling, redness, or dehiscence
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: