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NCT Number: NCT04385680

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

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.

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Key information

Conditions

Postpartum Endometritis Chlorhexidine Adverse Reaction Infections Postoperative Fever Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Armed Forces Hospitals Southern Region

Khamis Mushait, 62411, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine Gluconate vaginal solution 0.05%

Drug

preoperative vaginal preparation

Other names: No preparation or preparation with saline only

Primary outcomes

  1. post-cesarean endometritis

    Time frame: First 10 days post-cesarean

    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

  2. Postoperative wound infection

    Time frame: First month after cesarean

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

Secondary outcomes

  1. Significant leukocytosis

    Time frame: First 10 days postcesarean

    increase of WBCs count > 50% from preoperative count

  2. Chlorhexidine adverse drug reaction

    Time frame: First 10 days

    maternal or neonatal allergy or irritation

  3. incidence of hospital readmission

    Time frame: One month

    percent of cases needed readmission in both arms

  4. length of hospital stay

    Time frame: One month

    duration of hospitalization due to endometritis

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

The Impact of Chlorhexidine Preoperative Vaginal Preparation in Reducing the Post-cesarean Endometritis and Sepsis for Cases in Labor. A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 13, 2020
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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