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

Completed · Phase 3

Conditions studied: Wound Infection, Complication, Postoperative

In brief

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.

Key facts

Study ID

NCT02915289

Run by

Richmond University Medical Center

People needed

1114

Starts

2016-12-01

Expected to finish

2018-05-01

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Richmond University Medical Center — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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