search
Back to results

Chlorhexidine Vaginal Preparation for Reduction of Post-cesarean Endometritis and Sepsis

Primary Purpose

Postpartum Endometritis, Wound Infection, Chlorhexidine Adverse Reaction

Status
Completed
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Chlorhexidine Gluconate vaginal solution 0.05%
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Endometritis focused on measuring post-cesarean endometritis, wound infection, chlorhexidine vaginal preparation, chlorhexidine adverse reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Gestational age ≥28 weeks.
  2. Cases had cesarean section after start of labor.

Exclusion Criteria:

  1. Women with known allergy to chlorhexidine gluconate or any of its ingredients.
  2. Women with diagnosed group B streptococcus (GBS) colonization.
  3. Women with active infection during the procedure.
  4. Women did not receive the standard preoperative antibiotic prophylaxis.
  5. Women with diagnosis of chorioamnionitis.
  6. Prolonged rupture of membranes >7 days

Sites / Locations

  • Armed Forces Hospitals Southern Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chlorhexidine vaginal prep.arm

No vaginal antiseptic arm

Arm Description

Women in labor who will receive vaginal cleaning immediately before cesarean section using 50 ml of chlorhexidine gluconate 0.05% solution and standard abdominal scrub with chlorhexidine gluconate 4%. This concentration is indicated within the British National Formulary for swabbing in obstetrics. A swab soaked in the antiseptic will be used to clean the vagina for 30 seconds prior to CS at the time of urinary catheter insertion by long forceps. After the CS procedure, the vagina is always cleaned of excess blood as with a dry swab.

Women in labor who will receive abdominal scrub with chlorhexidine gluconate 4% only. Vaginal preparation is not including antiseptic or using normal saline only.

Outcomes

Primary Outcome Measures

post-cesarean endometritis
uterine fundal tenderness on bimanual examination ( physical examination: suprapubic tenderness, pain elicited by cervical motion, tenderness in parametrium, all during bimanual examination) + with fever (An oral temperature of 38°C or higher within the first 10 days postpartum or 38.7°C within the first 24 hours postpartum) ± purulent lochia requiring antibiotic therapy ( initial antibiotic will be started then waiting for proper therapy according to culture and sensitivity
Postoperative wound infection
erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.

Secondary Outcome Measures

Significant leukocytosis
increase of WBCs count > 50% from preoperative count
Chlorhexidine adverse drug reaction
maternal or neonatal allergy or irritation
incidence of hospital readmission
percent of cases needed readmission in both arms
length of hospital stay
duration of hospitalization due to endometritis

Full Information

First Posted
May 9, 2020
Last Updated
September 22, 2022
Sponsor
Zagazig University
search

1. Study Identification

Unique Protocol Identification Number
NCT04385680
Brief Title
Chlorhexidine Vaginal Preparation for Reduction of Post-cesarean Endometritis and Sepsis
Official Title
The Impact of Chlorhexidine Preoperative Vaginal Preparation in Reducing the Post-cesarean Endometritis and Sepsis for Cases in Labor. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

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
The study aims to assess the beneficial value of vaginal preparation with chlorhexidine gluconate 0.05% before cesarean delivery of cases in labor in reduction of postoperative endometritis, fever and wound complications compared to no preparation or using saline only.
Detailed Description
Despite the demonstrated effectiveness of the vaginal cleansing in the previous study, yet this has not been adopted within obstetric practice internationally and does not feature within the NICE Intrapartum guideline.7 This is may be due to concerns with exposure of the fetus to iodine-based substances, concerns with vaginal staining and allergy to iodine. Iodine is an antibacterial agent, but becomes inactive by the presence of blood may limit its use. Chlorhexidine show greater reduction in skin flora after application compared with povidone-iodine agents (0.5 and 4%) respectively and has a greater residual activity after application than other preparations and (unlike povidone iodine) it is not inactivated by the presence of blood. Thus, there are a number of reasons to believe that vaginal cleansing with chlorhexidine would be an appropriate alternative to povidone iodine.8 There is one RCT comparing povidone iodine with chlorhexidine gluconate for vaginal cleansing at CS. This suggested that chlorhexidine may be superior, and further research was needed.9 Solutions that contain lower concentrations, such as chlorhexidine gluconate and acetate (0.05%) are usually well tolerated and may be used for vaginal preparation. With this preparation, there are no reported cases of allergy.8 Importantly, no safety concerns for the mother or baby have been identified with chlorhexidine gluconate used for vaginal cleansing.10

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Endometritis, Wound Infection, Chlorhexidine Adverse Reaction, Postoperative Fever
Keywords
post-cesarean endometritis, wound infection, chlorhexidine vaginal preparation, chlorhexidine adverse reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine vaginal prep.arm
Arm Type
Experimental
Arm Description
Women in labor who will receive vaginal cleaning immediately before cesarean section using 50 ml of chlorhexidine gluconate 0.05% solution and standard abdominal scrub with chlorhexidine gluconate 4%. This concentration is indicated within the British National Formulary for swabbing in obstetrics. A swab soaked in the antiseptic will be used to clean the vagina for 30 seconds prior to CS at the time of urinary catheter insertion by long forceps. After the CS procedure, the vagina is always cleaned of excess blood as with a dry swab.
Arm Title
No vaginal antiseptic arm
Arm Type
No Intervention
Arm Description
Women in labor who will receive abdominal scrub with chlorhexidine gluconate 4% only. Vaginal preparation is not including antiseptic or using normal saline only.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate vaginal solution 0.05%
Other Intervention Name(s)
No preparation or preparation with saline only
Intervention Description
preoperative vaginal preparation
Primary Outcome Measure Information:
Title
post-cesarean endometritis
Description
uterine fundal tenderness on bimanual examination ( physical examination: suprapubic tenderness, pain elicited by cervical motion, tenderness in parametrium, all during bimanual examination) + with fever (An oral temperature of 38°C or higher within the first 10 days postpartum or 38.7°C within the first 24 hours postpartum) ± purulent lochia requiring antibiotic therapy ( initial antibiotic will be started then waiting for proper therapy according to culture and sensitivity
Time Frame
First 10 days post-cesarean
Title
Postoperative wound infection
Description
erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.
Time Frame
First month after cesarean
Secondary Outcome Measure Information:
Title
Significant leukocytosis
Description
increase of WBCs count > 50% from preoperative count
Time Frame
First 10 days postcesarean
Title
Chlorhexidine adverse drug reaction
Description
maternal or neonatal allergy or irritation
Time Frame
First 10 days
Title
incidence of hospital readmission
Description
percent of cases needed readmission in both arms
Time Frame
One month
Title
length of hospital stay
Description
duration of hospitalization due to endometritis
Time Frame
One month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age ≥28 weeks. Cases had cesarean section after start of labor. Exclusion Criteria: Women with known allergy to chlorhexidine gluconate or any of its ingredients. Women with diagnosed group B streptococcus (GBS) colonization. Women with active infection during the procedure. Women did not receive the standard preoperative antibiotic prophylaxis. Women with diagnosis of chorioamnionitis. Prolonged rupture of membranes >7 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Shafiek
Organizational Affiliation
Armed forces hospitals Southern Region KSA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hytham Atia
Organizational Affiliation
Armed Forces Hospitals Southern Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Hospitals Southern Region
City
Khamis Mushait
ZIP/Postal Code
62411
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26849801
Citation
Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
Results Reference
background
PubMed Identifier
28255256
Citation
Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.
Results Reference
background
PubMed Identifier
30016540
Citation
Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7(7):CD007892. doi: 10.1002/14651858.CD007892.pub6.
Results Reference
background

Learn more about this trial

Chlorhexidine Vaginal Preparation for Reduction of Post-cesarean Endometritis and Sepsis

We'll reach out to this number within 24 hrs