Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial |
- Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Enrollment: | 300 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vag prep
Vagina cleansed prior to performing cesarean
|
Procedure: Vaginal cleansing before cesarean delivery
Cleansing vagina with 1% betadine scrub before cesarean.
Other Name: 1% betadine scrub of vagina with vaginal scrub spongesticks.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts 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
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
No publications provided by Indiana University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David M. Haas/ Assistant Professor of OB/GYN, Indiana University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00386477 History of Changes |
| Other Study ID Numbers: | 0509-55 (Study #), 0509-55 |
| Study First Received: | October 9, 2006 |
| Results First Received: | November 11, 2009 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Povidone iodine postoperative infection presurgical cleansing |
Additional relevant MeSH terms:
|
Endometritis Surgical Wound Infection Wound Infection Pelvic Inflammatory Disease Adnexal Diseases Genital Diseases, Female Uterine Diseases Infection |
Postoperative Complications Pathologic Processes Wounds and Injuries Povidone-Iodine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013