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Completed

NCT Number: NCT02915289

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Richmond University Medical Center

Staten Island, New York, 10310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Povidone Iodine

Procedure

Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.

chlorhexidine gluconate

Procedure

Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.

Primary outcomes

  1. Postoperative wound infection

    Time frame: 0-14 days postpartum

    Erythema surrounding the incision site or pus-like incisional drainage in the presence or absence of fever

Secondary outcomes

  1. Postpartum endometritis

    Time frame: 0-14 days post-partum

    Clinical diagnosis with temperature of 100.4 degrees F or higher occurring 24 hours after surgery with uterine fundal tenderness or purulent lochia.

  2. Postoperative fever

    Time frame: 0-14 days post-partum

    Temperature greater than 38 degrees C or 100.4 degrees F

  3. Side effects

    Time frame: 0-14 days post-partum

    Patient reported side effects of vaginal preparation (allergy, irritation)

Sponsors and collaborators

Lead sponsor

Richmond University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2016
Registry last updated
Sep 14, 2018

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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