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

NCT06950229 | Completed

• 1 other identifier: AE-FUTHA/REC/VOL3/2020/069
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Conditions

Povidone Iodine; Normal Saline; Pre-operative

Keywords

Povidone Iodine; Normal Saline; Caesarean section; vaginal cleansing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Povidone group

ACTIVE COMPARATOR

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

Normal Saline

EXPERIMENTAL

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

Interventions

Povidone-Iodine DRUG

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.

Povidone group

Normal Saline DRUG

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.

Normal Saline

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

Location

MeSH Terms

Interventions

Povidone-Iodine; Saline Solution

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: October 6, 2020
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)