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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal and Vaginal Cleansing | Experimental | In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section. |
|
| Abdominal Cleansing Alone | Active Comparator | In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Cleansing | Procedure | The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Postoperative Infectious Morbidity | Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection. | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Reaction to Vaginal Cleansing | Hypersensitivity Reaction or more severe allergic reaction | 30 days postoperatively |
| Length of Hospital Stay | Days in hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Prespecified Stratified Analysis for Subgroups | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36462539 | Derived | Temming LA, Frolova AI, Raghuraman N, Tuuli MG, Cahill AG. Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial. Am J Obstet Gynecol. 2023 Jun;228(6):739.e1-739.e14. doi: 10.1016/j.ajog.2022.11.1300. Epub 2022 Nov 30. | |
| 32335895 | Derived | 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. |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D004716 | Endometritis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| Abdominal Cleansing | Procedure | The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean. |
|
| 30 days postoperatively |
| Number of readmissions to hospital for infectious morbidity. | Number of times patient is readdmitted for any infectious morbidity. | 30 days postoperatively |
| Treatment for neonatal Sepsis | Any antibioitics given for neonate with suspected sepsis. | 30 days postoperatively |
| Number of outpatient visits for infectious morbidiy. | Number of outpatient or emergency room visits related to infectious morbidity. | 30 days postoperatively. |
| 30 days postoperatively |
| Prespecified Stratified Analysis for Subgroups | Planned secondary analysis will be performed in order to obtain adjusted assessment of treatment effectiveness in subgroups stratified based on the following: administration of azithromycin and time of enrolment date in relation to hospital protocol adjustments for Covid19 screening. | 30 days postoperatively |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |