Clinical trial NCT06950229: Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section
Official title: Efficacy and Safety of Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Povidone Iodine
Normal Saline
Pre-operative
Keywords: Povidone Iodine
Normal Saline
Caesarean section
vaginal cleansing
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2025-04-30
Enrollment: 224
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and preoperative vaginal cleansing with povidone-iodine use in reduction of post-caesarean endometritis.Povidone iodine has been found to cause significant irritation to the vaginal mucosa especially in females with iodine hypersensitivity necessitating the study of efficacy of normal saline which has minimal side effects in the prevention of post caesarean complications

Detailed description: BACKGROUND: Maternal infectious morbidity is a common complication of caesarean section and is the third leading cause of maternal mortality in Nigeria and account for 15% of maternal death worldwide. Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with povidone-iodine (PI) was recommended in reduction of post-caesarean endometritis, but this may lead to significant irritation to the vaginal mucosa resulting from allergic reactions in females with iodine hypersensitivity. Normal saline (NS) is an effective cleaning solution and doesn't have allergic effect on healthy tissues. It is accessible, non-irritant, and less expensive in contrast to povidone iodine.

AIM: To compare the difference in the incidence of postoperative vaginal irritation symptoms and the rate of postoperative infections after using Povidone iodine versus Normal saline solution in vaginal cleansing before caesarean section at the Alex Ekwueme Federal University Teaching Hospital Abakaliki.

METHODOLOGY: This was a randomized controlled trial involving two hundred and twenty four (224) consenting pregnant women undergoing caesarean section in AE-FUTHA. These women were grouped into two arms; group 1 (Vaginal cleansing with povidone iodine) and group 2 (vaginal cleansing with normal saline solution). Both groups received prophylactic antibiotics and anterior abdominal wall scrubbing. Subsequently, the researcher and assistant reviewed the patients for infectious

morbidity daily during ward rounds till discharge and vaginal irritation symptoms 24hours postoperatively, and daily during ward round till discharge.

DATA ANALYSIS: Data was analyzed using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers, frequencies and percentages. Student t- test (t-test) was used for comparison between groups for quantitative variables while the chi- square was performed for comparing categorical variables. Relative risk and 95% confidence interval were calculated for outcome measures. A difference with a P value of \< 0.05 was taken to be statistically significant.

Eligibility criteria: Inclusion Criteria:

. All consenting parturient for either elective or emergency caesarean section after the age of viability

Exclusion Criteria:

* Women with known allergy to topical povidone-iodine.
* Women with presence of pre-existing vaginal irritation symptoms as itching, burning, swelling and vaginal pain.
* Antepartum haemorrhage (Placenta praevia).
* Cord prolapse
* Clinical evidence of Chorioamnionitis
* Face presentation with ruptured membranes to avoid contact of fetal face with iodine.
* Women with immunosupression due to HIV/AIDS, Diabetes Miletus or chronic use of steroids.

Primary outcomes:
measure: Post caesarean endometritis.
timeFrame: 24 hours
measure: Post operative vaginal irritation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital
state: Ebonyi
Study officials:
References: