Intra-abdominal at Cesarean Section: A Randomized Controlled Trial
The purpose of this study is to determine if intra-abdominal irrigation at the time of cesarean delivery increased maternal GI discomfort without affecting infection rates.
We hypothesized that avoiding intra-operative irrigation at the time of cesarean delivery will decrease intra-operative nausea and vomiting without increasing maternal infectious morbidity, post-operative pain, return of bowel function, or time to discharge.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Intra-abdominal at Cesarean Section: A Randomized Controlled Trial|
- Intra-operative nausea [ Time Frame: intra-operative ] [ Designated as safety issue: No ]Any nausea reported by the patient during the cesarean section
- Post operative GI disturbance [ Time Frame: 2-3 days post operatively ] [ Designated as safety issue: No ]Any nausea or vomiting reported or observed during the patient's postoperative period
- Infection [ Time Frame: 2-3 days post operatively ] [ Designated as safety issue: No ]Any documented infection during the patient's postoperative stay
|Study Start Date:||April 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Irrigation
This is the arm that will receive irrigation.
Procedure: Normal Saline Irrigation
Irrigation with warm normal saline into the abdominal cavity. Approximately 500-1000cc.
No Intervention: No Irrigation
This is the arm that will not receive irrigation.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479712
|United States, Virginia|
|Virginia Commonwealth University Hospital System|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Christine Isaacs, MD||VCU Department of Obstetrics and Gynecology|