Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section

Efficacy and Safety of Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pre-operative; Normal Saline; Povidone Iodine
• Intervention / Treatment: Drug: Povidone-Iodine; Drug: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Povidone group; Hundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.	Drug: Povidone-Iodine; Hundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.
Experimental: Normal Saline; Hundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.	Drug: Normal Saline; Hundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal Saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500 mg of metronidazole was given prior to the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post caesarean endometritis.	Patient that has at least two or more of the following signs and symptoms with no other recognized cause: fever greater than or equal to 380c, abdominal pain, uterine tenderness and purulent drainage from the uterus	24 hours
Post operative vaginal irritation	presence of symptoms like itching, burning, swelling and vaginal pain following the vaginal cleansing with either 5% povidone iodine or normal saline solution.	24 hours

Collaborators and Investigators

• Sponsor: Federal Teaching Hospital Abakaliki

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Caesarean section; Povidone Iodine; Normal Saline; vaginal cleansing
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Infective Agents, Local; Plasma Substitutes; Blood Substitutes; Povidone; Povidone-Iodine
• Other Study ID Numbers: AE-FUTHA/REC/VOL3/2020/069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No