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

NCT04385680 | Completed Phase 1

• 1 other identifier: chlorhex. post cs endometritis
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Endometritis; Wound Infection; Chlorhexidine Adverse Reaction; Postoperative Fever

Keywords

post-cesarean endometritis; wound infection; chlorhexidine vaginal preparation; chlorhexidine adverse reaction

Outcome Measures

Primary Outcomes (2)

• 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

  First 10 days post-cesarean

• Postoperative wound infection

  erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.

  First month after cesarean

Secondary Outcomes (4)

• Significant leukocytosis

  First 10 days postcesarean

• Chlorhexidine adverse drug reaction

  First 10 days

• incidence of hospital readmission

  One month

• length of hospital stay

  One month

Study Arms (2)

Chlorhexidine vaginal prep.arm

EXPERIMENTAL

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.

Drug: Chlorhexidine Gluconate vaginal solution 0.05%

No vaginal antiseptic arm

NO INTERVENTION

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

Interventions

Chlorhexidine Gluconate vaginal solution 0.05% DRUG

preoperative vaginal preparation

Also known as: No preparation or preparation with saline only

Chlorhexidine vaginal prep.arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Armed Forces Hospitals Southern Region

Khamis Mushait, 62411, Saudi Arabia

Location

Related Publications (3)

• 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.

  PMID: 26849801 BACKGROUND

• 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.

  PMID: 28255256 BACKGROUND

• 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.

  PMID: 30016540 BACKGROUND

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Ahmed Shafiek

  Armed forces hospitals Southern Region KSA

  PRINCIPAL INVESTIGATOR

• Hytham Atia

  Armed Forces Hospitals Southern Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Obstetrics & Gynecology

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 13, 2020
• Study Start: May 15, 2020
• Primary Completion: March 10, 2022
• Study Completion: August 30, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)