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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021315
• Other study ID #: 82019
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: Mohammed A Taymour, MD
• Phone: +201006588699
• Email: Mohammadtaymour[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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??

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 15, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Communicable Diseases
• Infections
• Postoperative Infection
• Surgical Wound Infection
• Vaginal Infection
• Wound Infection

Intervention

Drug:
• 10% povidone iodine
50 women who received preoperative vaginal cleansing with 10% povidone iodine.

Locations

Country	Name	City	State
Egypt	faculty of medicine - Cairo university	Cairo	Kasr El Ainy
Egypt	faculty of medicine, Kasr el ainy hospital, Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative wound complication	Any sign of infection as redness, hotness and tenderness as well as pyrexia occurance in wound postoperative	1 week