Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

NCT ID: NCT06936475

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-09-14

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.

Conditions

Endometritis; Vaginal Cleansing; Post Caesarean

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Povidone group

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.

Group Type: ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type: DRUG

5% povidone iodine

Chlorhexidine group

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.

Group Type: EXPERIMENTAL

Chlorhexidine Gluconate

Intervention Type: DRUG

0.5% chlorhexidine

Interventions

Povidone-Iodine

5% povidone iodine

Intervention Type: DRUG

Chlorhexidine Gluconate

0.5% chlorhexidine

Intervention Type: DRUG

Other Intervention Names

Povidone; Chlorhexidine

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal Teaching Hospital Abakaliki

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assumpta Nnenna Nweke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

Other Identifiers

FETHA/REC/VOL2/2019/294

Identifier Type: -

Identifier Source: org_study_id