Cesarean Section, Endometritis, Surgical Wound Infection
Conditions
Keywords
Povidone iodine, postoperative infection, presurgical cleansing
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.
Interventions
PROCEDUREVaginal cleansing before cesarean delivery
Cleansing vagina with 1% betadine scrub before cesarean.
Sponsors
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman undergoing cesarean delivery * At least 18 years of age
Exclusion criteria
* Allergy to iodine containing solutions * Planned cesarean hysterectomy * Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. | 1 month | Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vag Prep Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean | 155 |
| Control No vaginal cleansing or sham wash performed. | 145 |
| Total | 300 |
Baseline characteristics
| Characteristic | Vag Prep | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 155 Participants | 145 Participants | 300 Participants |
| Age Continuous | 26.8 years STANDARD_DEVIATION 5.9 | 26.6 years STANDARD_DEVIATION 5.7 | 26.7 years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized | 155 participants | 145 participants | 300 participants |
| Region of Enrollment United States | 155 participants | 145 participants | 300 participants |
| Sex: Female, Male Female | 155 Participants | 145 Participants | 300 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 155 | 0 / 145 |
| serious Total, serious adverse events | 0 / 155 | 0 / 145 |
Outcome results
Primary
Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.
Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.
Time frame: 1 month
Population: Randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vag Prep | Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. | 10 participants |
| Control | Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. | 17 participants |
p-value: 0.1195% CI: [0.26, 1.11]Chi-squared, Corrected