Complications; Cesarean Section
Conditions
Keywords
cesarean section, wound infection, vaginal cleansing, endometritis
Brief summary
The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
Detailed description
Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed. The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
Interventions
PROCEDUREVaginal Cleansing
The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
PROCEDUREAbdominal Cleansing
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.
Exclusion criteria
* Inability to obtain consent * known or suspected allergy to iodine or shellfish * women with active herpes simplex virus infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Postoperative Infectious Morbidity | 30 days postoperatively | Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Reaction to Vaginal Cleansing | 30 days postoperatively | Hypersensitivity Reaction or more severe allergic reaction |
| Length of Hospital Stay | 30 days postoperatively | Days in hospital |
| Treatment for neonatal Sepsis | 30 days postoperatively | Any antibioitics given for neonate with suspected sepsis. |
| Number of outpatient visits for infectious morbidiy. | 30 days postoperatively. | Number of outpatient or emergency room visits related to infectious morbidity. |
| Number of readmissions to hospital for infectious morbidity. | 30 days postoperatively | Number of times patient is readdmitted for any infectious morbidity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prespecified Stratified Analysis for Subgroups | 30 days postoperatively | Planned secondary analysis will be aimed at obtaining adjusted assessments of treatment effectiveness with interaction tests used to determine if the effectiveness of vaginal cleansing differs across subgroups. Subgroups include BMI categories, rupture status, chorioamnionitis, stage of labor, cervical dilation \>6 cm, gestational age, use of monitors, time in labor, duration of rupture, presence of GBS, labor status, and use of ripening agents. |
Countries
United States
Outcome results
None listed