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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02915289
Other study ID # 2016-08-04 RUMC
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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