Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection

Phase 3

• Conditions: Cesarean Section Complications; Vaginal Infection; Postoperative Infection
• Interventions: Drug: 10% povidone iodine

• Registration Number: NCT05021315
• Lead Sponsor: Cairo University

Brief Summary

The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection

Research questions:

Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection??

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-25
• Study Start: 2021-09-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

• 1. Pregnant women who are 37 weeks gestation or more scheduled for elective cesarean section or those in labor with a limited number of vaginal examinations less than 5 times preoperatively.

  2. Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours

  3. Women consenting to be included in the study.

Exclusion criteria:

1. Abnormally invasive placenta and placenta previa.
2. Intra-partum fever.
3. Prolonged rupture of membranes more than 24 hours
4. History of exposure to radiation treatment for cancer.
5. History of Gynecological infections (PID).
6. History of abdominal infections, e.g., peritonitis.
7. Debilitating diseases like Diabetes mellitus, Thyroid disorders, Cushing disease, abdominal malignancy.
8. Obesity is defined as pregnant BMI >30 kg/m2.
9. History of wound infection or burst abdomen.
10. History suggestive of massive bleeding during previous cesarean section.
11. allergy to iodine-containing solutions
12. Pregnant women with severe anemia defined as Hb <7 g/dl.
13. Cases with intra-abdominal drain deployment are discarded.
14. Obstructed labor with numerous vaginal examinations.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine group	10% povidone iodine	50 women who received preoperative vaginal cleansing with 10% povidone-iodine.

Primary Outcome Measures

Name	Time	Method
Postoperative wound complication	1 week	Any sign of infection as redness, hotness and tenderness as well as pyrexia occurance in wound postoperative

Trial Locations

Locations (2)

faculty of medicine - Cairo university; 🇪🇬 Cairo, Kasr El Ainy, Egypt

faculty of medicine, Kasr el ainy hospital, Cairo university; 🇪🇬 Cairo, Egypt