Clinical trial NCT00386477: Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
Official title: Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cesarean Section
Endometritis
Surgical Wound Infection
Keywords: Povidone iodine
postoperative infection
presurgical cleansing
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.

Detailed description: Infectious morbidity frequently complicates cesarean delivery. Endometritis can complicate the postoperative course of a cesarean delivery 6-27% of the time. This complication, up to 10 times more frequent than after vaginal delivery, can lead to serious complications. Additionally, cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma, hematoma, infection, and separation. These morbidities can lead to significant delay in a return to normal function. Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups. The control group will receive the standard surgical preparation of the abdomen alone, the current standard pre-cesarean preparation. The other group will also receive a povidone iodine washing/scrub of the vagina before the cesarean delivery. Maternal and surgical variables will be recorded. At one months postpartum, maternal outpatient data will be reviewed and the incidence of postpartum uterine infection, wound separations, and other wound and infectious complications will be determined and compared between the two treatment groups.

Comparison: Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery.

Eligibility criteria: Inclusion Criteria:

* Woman undergoing cesarean delivery
* At least 18 years of age

Exclusion Criteria:

* Allergy to iodine containing solutions
* Planned cesarean hysterectomy
* Prisoner

Primary outcomes:
measure: Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Memorial Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: David M Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
citation: Haas DM, Pazouki F, Smith RR, Fry AM, Podzielinski I, Al-Darei SM, Golichowski AM. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010 Mar;202(3):310.e1-6. doi: 10.1016/j.ajog.2010.01.005.