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

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.
Brief Title
RCT Investigating Pre-cesarean Vaginal Wash of Chlorhexidine vs Povidone-iodine for Patient With Ruptured Amniotic Membrane.
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.
Completion Date
Completion Date Type
Estimated
Conditions
Cesarean Section Complications
Eligibility 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.
Inclusion 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.

Gender
Female
Gender Based
false
Keywords
vaginal prep
randomization
chlorhexidine
povidone iodine
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
50 Years
Minimum Age
18 Years
NCT Id
NCT03925155
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-9948
Overall Status
Withdrawn
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
determine if there is any change of rates of postpartum endometritis amongst the chlorhexidine vaginal preparation group compared to povidone iodine group
Outcome Measure
Postpartum Endometritis
Outcome Time Frame
30 day postoperative
Secondary Outcomes
Outcome Description
Change of wound complication among postpartum 30 days after delivery
Outcome Time Frame
30 day postoperative
Outcome Measure
Rate of wound complications
Start Date
Start Date Type
Estimated
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Meleen Chuang
Investigator Email
mechuang@montefiore.org
Investigator Phone