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

Cesarean Section Complications Clinical Trial

— VAP  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03925155
• Other study ID #: 2019-9948
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: July 2020
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Rupture

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

References & Publications (2)

Ahmed MR, Aref NK, Sayed Ahmed WA, Arain FR. Chlorhexidine vaginal wipes prior to elective cesarean section: does it reduce infectious morbidity? A randomized trial. J Matern Fetal Neonatal Med. 2017 Jun;30(12):1484-1487. doi: 10.1080/14767058.2016.1219996. Epub 2016 Sep 1. — View Citation

Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7:CD007892. doi: 10.1002/14651858.CD007892.pub6. Review. Update — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum Endometritis	determine if there is any change of rates of postpartum endometritis amongst the chlorhexidine vaginal preparation group compared to povidone iodine group	30 day postoperative
Secondary	Rate of wound complications	Change of wound complication among postpartum 30 days after delivery	30 day postoperative