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

Federal Teaching Hospital Abakaliki

Status: Completed

Conditions: Post Cesarean Infectious Morbidity

Treatments: Procedure: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06176573

PVPVC2023CT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

First arm - Pre-operative vaginal cleansing with chlorhexidine

Active Comparator group

Description:

Had vaginal cleansing with chlorhexidine prior to cesarean section and were monitored for infectious morbidity.

Treatment:

Procedure: Chlorhexidine

Second arm - Post-operative vaginal cleansing with chlorhexidine

Active Comparator group

Description:

Had vaginal cleansing with chlorhexidine after cesarean section and were monitored for infectious morbidity.

Treatment:

Procedure: Chlorhexidine