Back to resultsUse of Antiseptic Solution for Vaginal Wash Before Cesarean Section
Primary Purpose
Operation Wound; Infection, Endometritis
Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Clorhexidine
Saline solution
Sponsored by
About this trial
This is an interventional prevention trial for Operation Wound; Infection focused on measuring Cesarean, Operative site infection, Vaginal wash, Clorhexidine, Endometritis
Eligibility Criteria
Inclusion Criteria:
- Women with gestation between 34 and 41 6/7 weeks.
- Premature rupture of membranes (> 6 hours).
- Use of prophylactic antibiotic 1 hour previous to cesarean section.
Exclusion Criteria:
- Any source of infection diagnosed previous to surgery.
- Fever of unknown origin previous to surgery.
Sites / Locations
- Saint Thomas Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clorhexidine
Saline solution
Arm Description
Vaginal wash with clorhexidine solution
Vaginal wash with saline solution
Outcomes
Primary Outcome Measures
Number of cases of endometritis after cesarean section
Endometritis
Secondary Outcome Measures
Number of cases of cesarean site infection
Operative site infection
Number of cases of fever (38°C or above) in the puerperium
Puerperal fever
Full Information
NCT ID
NCT03442218
First Posted
February 13, 2018
Last Updated
December 5, 2019
Sponsor
Saint Thomas Hospital, Panama
Collaborators
Sistema Nacional de Investigación (SNI) - Panamá
1. Study Identification
Unique Protocol Identification Number
NCT03442218
Brief Title
Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section
Official Title
Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
Collaborators
Sistema Nacional de Investigación (SNI) - Panamá
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operation Wound; Infection, Endometritis
Keywords
Cesarean, Operative site infection, Vaginal wash, Clorhexidine, Endometritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clorhexidine
Arm Type
Experimental
Arm Description
Vaginal wash with clorhexidine solution
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Vaginal wash with saline solution
Intervention Type
Drug
Intervention Name(s)
Clorhexidine
Intervention Description
Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.
Primary Outcome Measure Information:
Title
Number of cases of endometritis after cesarean section
Description
Endometritis
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Number of cases of cesarean site infection
Description
Operative site infection
Time Frame
15 days
Title
Number of cases of fever (38°C or above) in the puerperium
Description
Puerperal fever
Time Frame
15 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with gestation between 34 and 41 6/7 weeks.
Premature rupture of membranes (> 6 hours).
Use of prophylactic antibiotic 1 hour previous to cesarean section.
Exclusion Criteria:
Any source of infection diagnosed previous to surgery.
Fever of unknown origin previous to surgery.
Facility Information:
Facility Name
Saint Thomas Maternity Hospital
City
Panama
Country
Panama
12. IPD Sharing Statement
Citations:
PubMed Identifier
35051671
Citation
Urena N, Reyes O. Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100572. doi: 10.1016/j.ajogmf.2022.100572. Epub 2022 Jan 17.
Results Reference
derived
PubMed Identifier
32335895
Citation
Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Results Reference
derived
Learn more about this trial
Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section
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