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Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06936475
Enrollment
239
Registered
2025-04-20
Start date
2020-06-01
Completion date
2020-09-14
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometritis, Post Caesarean, Vaginal Cleansing

Keywords

chlorhexidine, Iodine, Endometritis, post caesarean, vaginal cleansing

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.

Interventions

DRUGPovidone-Iodine

5% povidone iodine

DRUGChlorhexidine Gluconate

0.5% chlorhexidine

Sponsors

Federal Teaching Hospital Abakaliki
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

Single blinded randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
post caesarean endometritis7 daysthe number of participants that will develop endometritis following use of either agents

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026