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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00386477 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cesarean Section Endometritis Surgical Wound Infection |
Procedure: Vaginal cleansing before cesarean delivery |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial |
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Vag prep: Experimental
Vagina cleansed prior to performing cesarean
|
Procedure: Vaginal cleansing before cesarean delivery
Cleansing vagina with betadine scrub before cesarean.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Memorial Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | David M Haas, MD | Indiana University School of Medicine |
More Information
| Responsible Party: | Indiana University School of Medicine ( David M. Haas/ Assistant Professor of OB/GYN ) |
| Study ID Numbers: | 0509-55 (Study #), 0509-55 |
| Study First Received: | October 9, 2006 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00386477 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Povidone iodine postoperative infection presurgical cleansing |
|
Communicable Diseases Endometritis Wounds and Injuries Uterine Diseases Disorders of Environmental Origin Pelvic Inflammatory Disease Surgical Wound Infection |
Infection Adnexal Diseases Genital Diseases, Female Pathologic Processes Postoperative Complications Wound Infection |