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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

RCT Investigating Pre-cesarean Vaginal Wash of Chlorhexidine vs Povidone-iodine for Patient With Ruptured Amniotic Membrane.

Clinicaltrials.gov identifier NCT03925155

Recruitment Status Withdrawn (The study was withdrawn from the IRB)

First Posted April 24, 2019

Last update posted July 7, 2020

Study Description

Brief summary:

The objective of this study is to investigate if the rate of infectious morbidity is decreased with the use of chlorhexidine or povidone-iodine vaginal scrub before cesarean section after ruptured membranes.

  • Condition or Disease:Cesarean Section Complications
  • Intervention/Treatment: Drug: EZ scrub vaginal chlorhexidine 4% solution
    Drug: 10% provodine-iodine vaginal preparation
  • Phase: Phase 3
Detailed Description

Postpartum endometritis is an infection of the endometrial lining of the uterus clinically diagnosed by fever and uterine fundal tenderness. The most important risk factor for developing endometritis is cesarean section, as it occurs in 11% of cesarean sections after labor and 3% of elective cesarean sections. Other risk factors for endometritis are chorioamnionitis, prolonged labor, prolonged rupture of membranes and vaginal colonization with Group B Streptococcus. Some complications of endometritis include prolonged hospital stay, sepsis, peritonitis and intrapelvic abscess. Surgical site infections are infections of the incision, organ or space after a procedure and are responsible for 38% of infections in patients undergoing surgery. In obstetric patients, infectious morbidity (wound complication, surgical site infections, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor. Current practices endorsed by ACOG and the CDC to reduce the incidence of infectious morbidity after cesarean section include pre-operative antibiotics and pre-operative skin cleansing with chlorhexidine skin preparation. Chlorhexidine and povidone-iodine are chemical antiseptics that reduces bacteria found on the skin. Additionally, vaginal scrub with 4% chlorhexidine gluconate and 10% povidone-iodine antiseptic solution immediately prior to cesarean section has been embraced into some practices as a means to decrease infectious morbidity. There is abundant literature showing pre-operative vaginal cleansing prior to hysterectomy has been shown to decrease vaginal surgical site antisepsis, however research on its use prior to cesarean section is limited. This study aims to assess the effectiveness of pre-operative vaginal scrub with 4% chlorhexidine or 10% povidone iodine in reducing infectious morbidity (specifically endometritis and SSI) in patients undergoing cesarean section with previously ruptured membranes. Current standard of care is use of pre-operative vaginal scrub with 10% povidone iodine. Patients will be randomized to one of two groups using pre-operative vaginal scrub for 30 seconds: 4% chlorhexidine or 10% povidone iodine. In addition both groups will receive pre-operative antibiotics with cefazolin and azithromycin, as well as abdominal cleansing with chlorhexidine-alcohol based skin preparation and 0.25% chlorhexidine wipe for 30 seconds, as this is standard of care for women undergoing cesarean section with ruptured membranes. In the event of penicillin allergy, antibiotics are adjusted accordingly.

Study Design
  • Study Type: Interventional
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: One arm is standard of care 10% povidone-iodine preparation, comparing with trial of chlorhexidine 4% vaginal preparation
  • Masking: Single (Participant)
  • Primary Purpose: Prevention
  • Official Title: A Randomized Trial to Investigate if a Pre-operative Wash With Chlorhexidine vs Povidone-iodine Vaginal Scrub Decreases Infectious Morbidity in Patients Undergoing Cesarean Section After Ruptured Membranes
  • Estimated Study Start Date: May 2020
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: May 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Chlorhexidine gluconate vaginal scrub
Use of chlorhexidine 4% vaginal scrub instead of current standard of care 10% povidone iodine vaginal scrub for cesarean sections
Drug: EZ scrub vaginal chlorhexidine 4% solution
Patients will be randomized to receive one of two solutions. Either chlorhexidine 4% solution or standard of care 10% provodine-iodine vaginal solution
Active Comparator: Povidone-iodine vaginal scrub
Current standard of care 10% povidone iodine vaginal scrub for cesarean sections
Drug: 10% provodine-iodine vaginal preparation
Patients will be randomized to receive one of two solutions. Either chlorhexidine 4% solution or standard of care 10% provodine-iodine vaginal solution
Outcome Measures
  • Primary Outcome Measures: 1. Postpartum Endometritis [ Time Frame: 30 day postoperative ]
    determine if there is any change of rates of postpartum endometritis amongst the chlorhexidine vaginal preparation group compared to povidone iodine group
  • Secondary Outcome Measures: 1. Rate of wound complications [ Time Frame: 30 day postoperative ]
    Change of wound complication among postpartum 30 days after delivery
Eligibility Criteria
  • Ages Eligible for Study: 18 to 50 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Females aged 18-50 years

- The study will be offered to women at > 24 weeks gestation who are undergoing
nonemergent cesarean delivery with ruptured amniotic membranes.

- All patients undergoing cesarean delivery with ruptured amniotic membranes.

Exclusion Criteria:

- Minors

- Emergent cesarean delivery.

- No ruptured membranes.

- Allergy to chlorhexidine or povidone-iodine.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Montefiore Medical Center

Investigators

Study Chair: Meleen Chuang, MD Montefiore Medical Center, Dept OB/GYN

More Information