Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

April 29, 2025 updated by: Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki

Post-Caesarean Vaginal Cleansing With Chlorhexidine Gluconate Versus Povidone Iodine for Prevention of Endometritis: A Randomised Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Ebonyi
      • Abakaliki, Ebonyi, Nigeria, 480101
        • Alex Ekwueme Federal University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Povidone-Iodine
5% povidone iodine
Other Names:
  • Povidone
Experimental: 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.
Drug: Chlorhexidine Gluconate
0.5% chlorhexidine
Other Names:
  • Chlorhexidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post caesarean endometritis
Time Frame: 7 days
the number of participants that will develop endometritis following use of either agents
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Teaching Hospital Abakaliki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

September 14, 2020

Study Completion (Actual)

September 14, 2020

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FETHA/REC/VOL2/2019/294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This will be made available following publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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