Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

NCT06936475 | Completed

• 1 other identifier: FETHA/REC/VOL2/2019/294
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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

Conditions

Endometritis; Vaginal Cleansing; Post Caesarean

Keywords

chlorhexidine; Iodine; Endometritis; post caesarean; vaginal cleansing

Outcome Measures

Primary Outcomes (1)

• post caesarean endometritis

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

  7 days

Study Arms (2)

Povidone group

ACTIVE COMPARATOR

In the povidone group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 5% povidone-iodine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol.

Drug: Povidone-Iodine

Chlorhexidine group

EXPERIMENTAL

In the chlorhexidine group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 0.5% chlorhexidine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol.

Drug: Chlorhexidine Gluconate

Interventions

Povidone-Iodine DRUG

5% povidone iodine

Also known as: Povidone

Povidone group

Chlorhexidine Gluconate DRUG

0.5% chlorhexidine

Also known as: Chlorhexidine

Chlorhexidine group

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

Location

MeSH Terms

Conditions

Endometritis

Interventions

Povidone-Iodine; Povidone; chlorhexidine gluconate; Chlorhexidine

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines

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

Model Details: Single blinded randomized controlled trial

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 20, 2025
• Study Start: June 1, 2020
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)