Pre-operative Versus Post-operative Vaginal Cleansing With Chlorhexidine Solution in Prevention Post-Cesarean Section Infection

Pre-operative Versus Post-operative Vaginal Cleansing With Chlorhexidine Solution in Prevention of Post-Cesarean Section Infectious Morbidity at a Teaching Hospital in a Resource Poor Setting: A Randomized Trial.

Maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. This study was done to compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities. Randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine.

Study Overview

• Status: Completed
• Conditions: Post Cesarean Infectious Morbidity
• Intervention / Treatment: Procedure: Chlorhexidine

Detailed Description

Background: Maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. This study was done in a tertiary hospital in Abakaliki, Ebonyi State, Southeast Nigeria over a period of 5 months. The State is inhabited mainly by rural farmers and petty traders. Literacy is low and poverty is common with poor maternal health indices.

Aim: To compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities.

Method: Randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine. Research Randomizer software was used to generate 120 numbers. Sixty numbers were randomly generated from a pool of 120 numbers and were assigned to group 1 while the remaining 60 numbers were automatically assigned to group 2. Both groups received antibiotics and anterior abdominal wall scrubbing. There were monitored for symptoms and signs of endometritis, wound infection and pyrexia till discharge.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ebonyi
    • Abakaliki, Ebonyi, Nigeria, 480001
      • Alex Ekwueme Federal University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Those that gave consent
• Term pregnancy

Exclusion Criteria:

• Refusal of consent
• Antepartum hemorrhage
• Cord prolapse
• Fetal distress
• Anemia in pregnancy
• Presence of fever and chorioamnionitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First arm - Pre-operative vaginal cleansing with chlorhexidine; Had vaginal cleansing with chlorhexidine prior to cesarean section and were monitored for infectious morbidity.	Procedure: Chlorhexidine; Pre-operative and post-operative vaginal cleansing.; Other Names: Antibiotic prophylaxis
Active Comparator: Second arm - Post-operative vaginal cleansing with chlorhexidine; Had vaginal cleansing with chlorhexidine after cesarean section and were monitored for infectious morbidity.	Procedure: Chlorhexidine; Pre-operative and post-operative vaginal cleansing.; Other Names: Antibiotic prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infectious morbidity	development of infectious morbidity following cesarean section after vaginal cleansing.	six (6) weeks.

Collaborators and Investigators

• Sponsor: Federal Teaching Hospital Abakaliki

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Estimated): December 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 16, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Anti-Bacterial Agents; Chlorhexidine
• Other Study ID Numbers: PVPVC2023CT

Drug and device information, study documents

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