NCT06176573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 8, 2023

Last Update Submit

December 16, 2023

Conditions

Post Cesarean Infectious Morbidity

Outcome Measures

Primary Outcomes (1)

  • infectious morbidity

    development of infectious morbidity following cesarean section after vaginal cleansing.

    six (6) weeks.

Study Arms (2)

First arm - Pre-operative vaginal cleansing with chlorhexidine

ACTIVE COMPARATOR

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

Procedure: Chlorhexidine

Second arm - Post-operative vaginal cleansing with chlorhexidine

ACTIVE COMPARATOR

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

Procedure: Chlorhexidine

Interventions

ChlorhexidinePROCEDURE

Pre-operative and post-operative vaginal cleansing.

Also known as: Antibiotic prophylaxis
First arm - Pre-operative vaginal cleansing with chlorhexidineSecond arm - Post-operative vaginal cleansing with chlorhexidine

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Those that gave consent
  • Term pregnancy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480001, Nigeria

Location

MeSH Terms

Interventions

ChlorhexidineAntibiotic Prophylaxis

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsChemopreventionDrug TherapyTherapeuticsPremedication

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2023

First Posted

December 19, 2023

Study Start

April 1, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations

NG(1)