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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2022-08-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Postpartum Endometritis Wound Infection Chlorhexidine Adverse Reaction Postoperative Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Chlorhexidine vaginal prep.arm

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.

Group Type EXPERIMENTAL

Chlorhexidine Gluconate vaginal solution 0.05%

Intervention Type DRUG

preoperative vaginal preparation

No vaginal antiseptic arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chlorhexidine Gluconate vaginal solution 0.05%

preoperative vaginal preparation

Intervention Type DRUG

Other Intervention Names

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No preparation or preparation with saline only

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No