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Intra-abdominal at Cesarean Section: A Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01479712
First received: November 22, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Nausea
Vomiting
 Procedure: Normal Saline Irrigation

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Intra-operative nausea [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
    Any nausea reported by the patient during the cesarean section


Secondary Outcome Measures:
  • 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


Enrollment: 263
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women
  • 18 years of age or older
  • presenting to MCV Hospital
  • undergoing obstetrically indicated cesarean section
  • english speaking

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479712

Locations
United States, Virginia
Virginia Commonwealth University Hospital System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Christine Isaacs, MD VCU Department of Obstetrics and Gynecology
  More Information

No publications provided by Virginia Commonwealth University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01479712     History of Changes
Other Study ID Numbers: HM11572
Study First Received: November 22, 2011
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Irrigation
Cesarean Section
Nausea
Infection

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013