NCT01479712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

November 22, 2011

Last Update Submit

November 22, 2011

Conditions

NauseaVomiting

Keywords

IrrigationCesarean SectionNauseaInfection

Outcome Measures

Primary Outcomes (1)

  • Intra-operative nausea

    Any nausea reported by the patient during the cesarean section

    intra-operative

Secondary Outcomes (2)

  • Post operative GI disturbance

    2-3 days post operatively

  • Infection

    2-3 days post operatively

Study Arms (2)

Irrigation

ACTIVE COMPARATOR

This is the arm that will receive irrigation.

Procedure: Normal Saline Irrigation

No Irrigation

NO INTERVENTION

This is the arm that will not receive irrigation.

Interventions

Normal Saline IrrigationPROCEDURE

Irrigation with warm normal saline into the abdominal cavity. Approximately 500-1000cc.

Irrigation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University Hospital System

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Viney R, Isaacs C, Chelmow D. Intra-abdominal irrigation at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1106-11. doi: 10.1097/AOG.0b013e3182460d09.

    PMID: 22617574DERIVED

MeSH Terms

Conditions

NauseaVomitingInfections

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christine Isaacs, MD

    VCU Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 24, 2011

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

US(1)