Clinical Trial: Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Brief Summary: Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
Detailed Summary:
Study Population:
Women undergoing cesarean sections will be enrolled in this study after obtaining verbal consent as there are no extra interventional measures that will be undertaken in the study apart from routine investigations and procedures done during cesarean sections, being already approved in signed consent to undergo treatment.
The nature and aim of the work will be fully discussed to all women who will agree to participate in the study. Verbal consent will be obtained from all patients enrolled in the study which is approved by the local ethical committee.
Preoperative evaluation of patients included:
-
Medical history taking including:
- Personal (name, age)
- Complaint (in patient word)
- Present history
- Medical history (Diabetes mellitus, Hypertension)
- Past history (any surgeries)
- Family history
- Physical examination including vital data (blood pressure,pulse, temperature)
- Routine hematologic laboratory tests including complete blood picture & random blood sugar.
- The surgical site will be assessed at least once before cesarean section if the participant presented to emergency department with findings concerning for surgical-site infection.
- Indication for cesarean section.
- Duration of ruptured membranes
Sponsor: Ain Shams Maternity Hospital
Current Primary Outcome: Number of Subjects with post cesarean endometritis [ Time Frame: 48 hours ]
Number of Subjects with post cesarean endometritis as diagnosed by fever 38.4°C and greater in first 48 hours after cesarean section with any of the following (uterine tenderness, foul smelling lochia or positive C-reactive protein)
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of Subjects with allergic reaction to povidone iodine [ Time Frame: 48 hours ]
Number of Subjects with allergic reaction to povidone iodine
Original Secondary Outcome: Same as current
Information By: Ain Shams Maternity Hospital
Dates:
Date Received: February 15, 2016
Date Started: April 2015
Date Completion: October 2016
Last Updated: February 25, 2016
Last Verified: February 2016
