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.

  Hide Detailed Description

Detailed Description:

This study will be a prospective randomized controlled trial.

Based on available literature and clinical experience, we expect a twenty percent decrease in gastrointestinal disturbances by avoiding intraoperative irrigation at the time of cesarean section. With the type 1 error rate set at 0.05 and a power of 0.90; this will require 184 patients in each arm (irrigation versus no irrigation) to obtain an adequate sample size. Paper copies of written consent and any identifying information will be kept in a secured, locked file. All data collected will be stored in a password protected computer file that will be accessible only to the investigators.

Patients will be identified at the time of admission to the Labor and Delivery unit. A physician will discuss the study with the patient. After time for consideration and having had all questions answered the patient will then be consented for the trial. Consent will be obtained at the time of admission to the Labor and Delivery unit. If the patient has a successful vaginal delivery the patient will not enter the study. If the patient requires a cesarean section the patient will be randomized either in to an irrigation or a nonirrigation group. Assignment will be performed by pulling sequentially numbered opaque envelopes containing computer-randomized individual allocations. This randomization will be carried out by research staff before the initiation of the study, and the patients will be blinded to treatment once assigned. Information regarding basic demographic data, comorbidities that may affect infection rates (diabetes, hypertension, ect), interventions during labor, and post partum course will be obtained from the patients' charts.

The two arms will differ only in intraoperative management of the patient after delivery of the baby. Patients in the irrigation arm will receive a cesarean section with irrigation of the abdominal cavity with 500-1000mL of warm normal saline after closure of the uterine incision but prior to the closure of the abdominal wall. In addition all blood clots and other debris will be evacuated from the paracolic gutters, anterior and posterior culdesacs, and under the bladder flap. The nonirrigation group will receive Joel-Cohen cesarean section without the irrigation with normal saline. This group will also have any large debris including blood clots evacuated. Both groups will undergo standard closure of the abdominal wall, including reapproximation of the rectus muscles and suturing of the rectus fascia with running nonlocking absorbable suture. Prefascial irrigation of the subcutaneous tissues superior to the closed fascia will be done in both groups. Staples or absorbable suture will be used for skin closure. In addition all patients will receive a standardized dose of 1 gram of a first generation cephalosporin or 900mg clindamycin intravenously as antibiotic prophylaxis at the time of umbilical cord clamping.

As per standard of care, the post partum care will include vital signs every 4 hours including patient report of pain level and nausea, discontinuation of the foley catheter and advancement of the diet on postoperative day one, daily examination of the incision, notation of return of gastrointestinal function, early ambulation, and a complete blood count on the first postoperative day.

The primary outcome of measure will be maternal GI disturbance. This will be defined as nausea or emesis during the cesarean section as well as any nausea requiring medical intervention during her hospitalization. The time to return of bowel function will also be recorded. The secondary outcome of measure is the incidence of maternal infectious morbidity, defined as endometritis. This will be diagnosed with two or more of the following are present: abnormally tender uterus on exam, temperature greater than 100.4°F at any time postoperatively, unexplained maternal tachycardia greater than 100 beats per minute. Patients will also be monitored for wound infections daily by visual inspection of the incision. Diagnosis will be made if any erythema, tenderness, discharge or separation occurs with maternal fever. Post operative care providers will be blinded to group assignment to avoid any potential bias.

The investigators will collect the data, perform data entry, and review charts to ensure accuracy of information provided by the treating physician. Periodic reviews of the data entry will be performed to ensure completeness and accuracy.

  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 August 20, 2014