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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | the control group has only prophylactic antibiotics according to hospital protocols. | |
| Clindamycin vaginal cream | Experimental | Clindamycin vaginal cream one applicator each night for 3 nights before CS. |
|
| Vaginal preparation with povidone- iodide solution 10 % | Experimental | Vaginal preparation with povidone- iodide solution 10 % before skin incision with sponge sticks prior to caesarean section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin vaginal cream | Drug | Clindamycin vaginal cream one applicator each night for 3 nights before CS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection (surgical site infection SSI) | erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Abdallah Salem, MD | Contact | 201272842226 | sara.abdalla@med.bsu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni suef university | Recruiting | Banī Suwayf | Egypt |
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| Vaginal preparation with povidone- iodide solution 10 % | Drug | Vaginal preparation with povidone- iodide solution 10 % |
|
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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