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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014