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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05021315

Collaborator

(none)

800

Enrollment

Locations

Arms

Anticipated Duration (Months)

400

Patients Per Site

30.8

Patients Per Site Per Month

Study Details

Study Description

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??

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications Vaginal Infection Postoperative Infection	Drug: 10% povidone iodine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 15, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iodine group 50 women who received preoperative vaginal cleansing with 10% povidone-iodine.	Drug: 10% povidone iodine 50 women who received preoperative vaginal cleansing with 10% povidone iodine. Other Names: Betadine
No Intervention: Control group 50 women who did not receive preoperative vaginal cleansing even with tap water.

Arm

Intervention/Treatment

Experimental: Iodine group

50 women who received preoperative vaginal cleansing with 10% povidone-iodine.

Drug: 10% povidone iodine

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

Other Names:

Betadine

No Intervention: Control group

50 women who did not receive preoperative vaginal cleansing even with tap water.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours
Women consenting to be included in the study.

Exclusion criteria:

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