Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

Not Applicable

Completed

• Conditions: Endometritis; Vaginal Cleansing; Post Caesarean
• Interventions: Drug: Chlorhexidine Gluconate; Drug: Povidone-Iodine

• Registration Number: NCT06936475
• Lead Sponsor: Federal Teaching Hospital Abakaliki

Brief Summary

Povidone has been approved for vaginal cleansing in the prevention of endometritis postcaesarean section. chlorhexidine solution which is cheap and readily available as shown to prevent endometritis.The aim of this study is to compare the effectiveness of post-operative vaginal cleansing with povidone-iodine versus chlorhexidinegluconate in reducing post-caesarean maternal endometritis

Detailed Description

BACKGROUND: Maternal infectious morbidity is a common complication of caesarean section and is the third leading cause of maternal mortality in Nigeria. It accounts for 15% of maternal death worldwide. Post-caesarean maternal infectious morbidity (endometritis) is still a big challenge despite prophylactic antibiotics and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with povidone-iodine was conditionally recommended in reduction of post-caesarean endometritis by WHO but in some emergent conditions, the practice may not be feasible. There is need to research effective post-caesarean vaginal cleansing antiseptic agents which may offer benefits in such emergent conditions.

AIM: To compare the effectiveness of post-operative vaginal cleansing with povidone-iodine versus chlorhexidinegluconate in reducing post-caesarean maternal endometritis at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA).

METHODOLOGY: This was a single blinded randomized controlled trial involving two hundred and forty four (244) consenting pregnant women booked for emergency lower segment Caesarean section at AEFUTHA and Mile 4 Hospital, Abakaliki; with 122 women randomized into the Povidone-iodine arm (control arm) and 122 into the Chlorhexidinegluconate arm. Both groups received prophylactic antibiotics and anterior abdominal wall scrubbing. The control group received post-operative vaginal cleansing with Povidone iodine while study group received chlorhexidinegluconate. immediately after skin closure. Subsequently, they were reviewed for endometritis daily till discharge or up to 7 days for patients who had the need to stay up to 7 days or beyond. Data was analyzed using statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± 2SD), while categorical variables were presented as numbers, frequencies and percentages. Student t test was used for comparison between groups for continuous variables and mean of the two groups. Chi-square test was used for comparison between groups for categorical variables.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-09-14
• Study Completion: 2020-09-14
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-20
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

Inclusion Criteria

• All pregnant women at > 28 weeks gestational age undergoing emergency caesarean section.
• Emergency caesarean sections for women in labour, with ruptured membrane or cord prolapse.
• Pregnant women that gave consent to participate in the study

Exclusion Criteria

• Elective caesarean sections
• Known allergy to povidone iodine or chlorhexidinegluconate
• Diabetes mellitus/ glucose intolerance undergoing elective caesarean section.
• Asymptomatic placenta praevia undergoing elective caesarean section
• Patients who have chorioamnionitis
• Immunosuppressive conditions like AIDS, steroid use
• Patients who have coexisting uterine fibroid.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine group	Chlorhexidine Gluconate	In the chlorhexidine group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 0.5% chlorhexidine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol.
Povidone group	Povidone-Iodine	In the povidone group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 5% povidone-iodine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol.

Primary Outcome Measures

Name	Time	Method
post caesarean endometritis	7 days	the number of participants that will develop endometritis following use of either agents

Trial Locations

Locations (1)

Alex Ekwueme Federal University Teaching Hospital; 🇳🇬 Abakaliki, Ebonyi, Nigeria