Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery

Wound Infection Clinical Trial

Official title:

Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery: A Randomized Comparator Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915289
• Other study ID #: 2016-08-04 RUMC
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: May 2018

Study information

• Verified date: September 2018
• Source: Richmond University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endometritis, an infection of the uterus in the postpartum period, has been shown to complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal cleansing prior to cesarean delivery has been shown to minimize the presence of micro-organisms and risk of infection. Although povidone-iodine is the most commonly used anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine gluconate, on the other hand, has demonstrated superior disinfectant properties in several clinical trials, as compared to povidone iodine. In this randomized, comparator controlled, study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.

Description:

This is a randomized, comparator controlled, study of intrapartum vaginal preparation with either chlorhexidine gluconate or povidone-iodine solution. Women undergoing non-emergent cesarean delivery will be randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% providone-iodine solution.

The study will have two arms that will be randomized in a 1:1 ratio. After inclusion criteria have been satisfied, subjects in the comparator control arm will receive vaginal preparation with 10% provodone-iodine solution prior the skin incision. Subjects in the study arm will receive vaginal preparation with chlorohexidine gluconate 4% solution. The selected skin preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. A block randomization method will be used to control for variations in care. Both groups will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1114
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at Richmond University Medical Center that have a non-emergent cesarean delivery

Exclusion Criteria:

• Emergent cesarean delivery, less than 18 years of age, chorioamnionitis before randomization, intrapartum fever prior to randomization, or known or suspected allergy to chlorhexidine or iodine.

Related Conditions & MeSH terms

• Complication, Postoperative
• Postoperative Complications
• Wound Infection

Intervention

Procedure:
• Povidone Iodine
Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.
• Chlorhexidine gluconate
Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.

Locations

Country	Name	City	State
United States	Richmond University Medical Center	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Richmond University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative wound infection	Erythema surrounding the incision site or pus-like incisional drainage in the presence or absence of fever	0-14 days postpartum
Secondary	Postpartum endometritis	Clinical diagnosis with temperature of 100.4 degrees F or higher occurring 24 hours after surgery with uterine fundal tenderness or purulent lochia.	0-14 days post-partum
Secondary	Postoperative fever	Temperature greater than 38 degrees C or 100.4 degrees F	0-14 days post-partum
Secondary	Side effects	Patient reported side effects of vaginal preparation (allergy, irritation)	0-14 days post-partum