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Completed

NCT Number: NCT06936475

Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

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

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Key information

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povidone-Iodine

Drug

5% povidone iodine

Other names: Povidone

Chlorhexidine gluconate

Drug

0.5% chlorhexidine

Other names: Chlorhexidine

Primary outcomes

  1. post caesarean endometritis

    Time frame: 7 days

    the number of participants that will develop endometritis following use of either agents

Sponsors and collaborators

Lead sponsor

Federal Teaching Hospital Abakaliki

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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