Actively Recruiting
Comparative Study of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
Led by Beni-Suef University · Updated on 2026-03-16
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the effects of preoperative use of clindamycin vaginal cream compared to vaginal cleansing with a 10% povidone-iodine solution on infections after cesarean section. It focuses on postpartum infectious complications, particularly surgical site infections, in women undergoing elective cesarean sections. The study is a randomized, single-blind phase 4 trial sponsored by Beni-Suef University, aiming to improve infection control methods for this group. Participants are randomly assigned to one of three groups: a control group receiving standard prophylactic antibiotics only, a group using clindamycin vaginal cream applied nightly for three nights before surgery, or a group receiving vaginal cleansing with povidone-iodine solution just before skin incision. All participants receive standard spinal anesthesia, catheterization, antiseptic skin preparation, and postoperative antibiotics according to hospital protocols. Education on wound care and infection symptoms is provided to all. During the study, participants are monitored for signs of infection up to three weeks after surgery. Evaluations include clinical assessments of the surgical site and symptoms such as fever, discharge, pain, swelling, redness, or wound opening. The primary outcome is the occurrence of wound infection within three weeks. Participants receive routine postoperative care and are advised to seek hospital care if infection symptoms appear. The total participation period includes the preoperative treatment and the three-week follow-up.
CONDITIONS
Brief Title
Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants with singleton pregnancies scheduled for elective cesarean sections at term between 37 and 40 weeks of gestation
- Participants aged 18 to 40 years
- Body mass index (BMI) between 18 and 30 kg/m2
- Free from any medical disorders
You will not qualify if you...
- Urgent or emergent cesarean section cases
- Abnormal vaginal secretions such as bad smelling yellowish discharge, whitish cheesy discharge with itching, or bloody discharge
- Medical disorders including pre-gestational diabetes, anemia, hypertension, preeclampsia, or immunosuppression
- Skin infection near the surgical site
- Allergy to topical povidone-iodine or clindamycin
- Fever, history of premature rupture of membranes, or placenta previa
- Patients lost during follow-up
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 nights before cesarean section and surgery day
Participants receive either clindamycin vaginal cream each night for 3 nights before cesarean section, vaginal preparation with povidone-iodine solution before skin incision, or prophylactic antibiotics according to hospital protocol during surgery.
1 to 4 visits including preoperative and surgery day
Duration - Up to 3 weeks after cesarean section
Participants receive routine postoperative care and are advised to return to the hospital if symptoms of infection develop. Antibiotics are given for 5 days after discharge.
Approximately 1 follow-up visit and additional visits if symptoms occur
Trial Site Locations
Total: 1 location
1
Beni suef university
Banī Suwayf, Egypt
Actively Recruiting
Research Team
S
Sara Abdallah Salem, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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