Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02693483|
Recruitment Status : Unknown
Verified February 2016 by Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital.
Recruitment status was: Recruiting
First Posted : February 26, 2016
Last Update Posted : February 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infection; Cesarean Section||Drug: 10% povidone iodine||Phase 4|
Hide Detailed Description
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 if found.
- Risk of infection including Diabetes mellitus, immuno-compromised, rupture of membranes and corticosteroid therapy.
Patients In the study group (povidone iodine group) patients will be prepared with vaginal cleansing with povidone-iodine along with the usual abdominal scrub. Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall. After vaginal cleansing the gloves will be changed to perform the abdominal scrub.
Patients in the control group (no vaginal cleansing group) will not have any vaginal wash (even tap water will not be used).
In both groups, patients will receive preoperative per protocol prophylactic I.V. antibiotics (third generation cephalosporin ) before skin incision.
During this study all cases will be subjected to exclusion and inclusion criteria. Any risk of infection will be assessed including rupture of membranes, Diabetes mellitus, immune-compromised and corticosteroid therapy….etc. Cesarean section will be performed with estimation of operative duration in time and mean operative blood loss.
Post operative care:
Follow up for temperature of 38°C and greater during first 24 hours of surgery and endometritis will be diagnosed by fever 38.4°C and greater with any of the following (uterine tenderness ,foul smelling lochia or positive C-reactive protein).
Mean hospital stay in days will be determined. N.B: Culture of the upper genital tract are virtually impossible to obtain without contaminating the specimen by the microorganisms in the vagina. Therefore, they rarely add significant information that enhances clinical decision-making.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||October 2016|
Active Comparator: povidone iodine
153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine
Drug: 10% povidone iodine
Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall
Other Name: betadine
No Intervention: no vaginal cleansing
153 cases undergoing cesarean sections
- 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)
- Number of Subjects with allergic reaction to povidone iodine [ Time Frame: 48 hours ]Number of Subjects with allergic reaction to povidone iodine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693483
|Contact: Amr A Riad, MD||01005347179 ext +firstname.lastname@example.org|
|Ain Shams maternity hospital||Recruiting|