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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06176573
Enrollment
120
Registered
2023-12-19
Start date
2021-04-01
Completion date
2021-08-31
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Cesarean Infectious Morbidity

Brief summary

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

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.

Interventions

PROCEDUREChlorhexidine

Pre-operative and post-operative vaginal cleansing.

Sponsors

Federal Teaching Hospital Abakaliki
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
infectious morbiditysix (6) weeks.development of infectious morbidity following cesarean section after vaginal cleansing.

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026