Infection; Cesarean Section Clinical Trial
Official title:
Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
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:
1. Medical history taking including:
- Personal (name, age)
- Complaint (in patient word)
- Present history
- Medical history (Diabetes mellitus, Hypertension)
- Past history (any surgeries)
- Family history
2. Physical examination including vital data (blood pressure,pulse, temperature)
3. Routine hematologic laboratory tests including complete blood picture & random blood
sugar.
4. 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.
5. Indication for cesarean section.
6. Duration of ruptured membranes if found.
7. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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