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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Post Cesarean Infectious Morbidity

Intervention / Treatment
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* Procedure: Chlorhexidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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