Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Primary Purpose
Infection; Cesarean Section
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
10% povidone iodine
Sponsored by
About this trial
This is an interventional prevention trial for Infection; Cesarean Section
Eligibility Criteria
Inclusion Criteria:
- Patients 18-40 years of age who will undergo cesarean deliveries.
- Able to communicate well with the investigator & to comply with the requirements of the entire study.
- Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice).
Exclusion Criteria:
- Patients with allergy to iodine containing solutions.
- Patients with ante-partum hemorrhage.
- Patients with ruptured membranes.
- Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc.
Sites / Locations
- Ain Shams maternity hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
povidone iodine
no vaginal cleansing
Arm Description
153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine
153 cases undergoing cesarean sections
Outcomes
Primary Outcome Measures
Number of Subjects with post cesarean endometritis
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)
Secondary Outcome Measures
Number of Subjects with allergic reaction to povidone iodine
Number of Subjects with allergic reaction to povidone iodine
Full Information
NCT ID
NCT02693483
First Posted
February 15, 2016
Last Updated
February 25, 2016
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02693483
Brief Title
Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Official Title
Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
Detailed Description
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 if found.
Risk of infection including Diabetes mellitus, immuno-compromised, rupture of membranes and corticosteroid therapy.
Steps:
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.
Operative technique:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection; Cesarean Section
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
povidone iodine
Arm Type
Active Comparator
Arm Description
153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine
Arm Title
no vaginal cleansing
Arm Type
No Intervention
Arm Description
153 cases undergoing cesarean sections
Intervention Type
Drug
Intervention Name(s)
10% povidone iodine
Other Intervention Name(s)
betadine
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Subjects with post cesarean endometritis
Description
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)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of Subjects with allergic reaction to povidone iodine
Description
Number of Subjects with allergic reaction to povidone iodine
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients 18-40 years of age who will undergo cesarean deliveries.
Able to communicate well with the investigator & to comply with the requirements of the entire study.
Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice).
Exclusion Criteria:
Patients with allergy to iodine containing solutions.
Patients with ante-partum hemorrhage.
Patients with ruptured membranes.
Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A Riad, MD
Phone
01005347179
Ext
+2
Email
amr.riad@med.asu.edu.eg
Facility Information:
Facility Name
Ain Shams maternity hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32335895
Citation
Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Results Reference
derived
Learn more about this trial
Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
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