Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Cesarean Section Via Enhanced Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552822
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Mark Powell, University of Alabama at Birmingham

Brief Summary:

Enhanced Recovery After Surgery (ERAS) protocols have been proven to be very successful in specific patient populations. An example is with ERAS for colorectal surgery. ERAS protocols in this patient population have been shown to reduce overall morbidity and hospital length of stay (LOS). At the University of Alabama at Birmingham (UAB), the institution has had successful implementation of ERAS protocols for several surgical specialties including colorectal, breast, spine, gynecology, and gynecology-oncology. However, the institution currently does not have a protocol in place for the most commonly performed surgical procedure - cesarean delivery. At UAB, the institution performs approximately 1,000 cesarean deliveries per year.

The investigators believe that an ERAS protocol will be beneficial for these patients. Currently, there is very little data published on ERAS protocols. Although this patient population is ideal for an ERAS protocol, there are several barriers that have to be overcome. The data published show promising results for ERAS protocols with cesarean delivery. A larger tertiary care center showed earlier discharge with lower re-admission rates with an ERAS pathway.

Currently, the investigators have created a multidisciplinary group at UAB to establish an ERAS protocol for patients undergoing cesarean delivery. This group includes anesthesiologists, obstetricians, nursing, neonatology, pharmacy, and informatics. Once the investigators have implemented this protocol, the investigators would like to perform a retrospective analysis to determine if there are any significant changes in our desired outcomes the investigators will study. Our goal is to demonstrate significantly improved outcomes in the investigators' measured endpoints. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for cesarean deliveries, there currently is very little published on the subject. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.


Condition or disease Intervention/treatment
Cesarean Section Other: ERAS Protocol Implementation

Detailed Description:
The investigators are implementing an enhanced recovery after surgery (ERAS) protocol for patients undergoing cesarean delivery. The purpose of the ERAS protocol is to optimize care provided to patients (patient education, nutrition, pain management, early ambulation, etc.). The anticipated date of protocol initiation is May 2018. Once this protocol has been in place for approximately 6 months to one year, the investigators would like to retrospectively review data on these patients and compare outcomes to a similarly-matched group of patients the year preceding protocol implementation. Specific outcomes the investigators will assess are: hospital length of stay, post-operative pain scores, opioid consumption, patient satisfaction [through IRB-approved survey (protocol X300001121)], surgical site infection rates, readmission rates, and unscheduled clinic and maternal evaluation unit (MEU) visits before the first scheduled postpartum visit. The investigators also plan to track compliance monthly with the adherence to the protocol. Since the investigators want to track compliance (both as a quality improvement project as well as research), the investigators are requesting (Institutional Review Board) IRB approval now.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes in Patients Undergoing Cesarean Section Via the Enhanced Recovery After Surgery (ERAS) Pathway: a Retrospective Study
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort Intervention/treatment
ERAS Implemented Group
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
Other: ERAS Protocol Implementation
Implementation of ERAS Protocol Implementation

Pre-ERAS - Non-ERAS Implemented Group
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.



Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: From 1 to 72 hours post surgery ]
    Measurement of opioid consumption in oral morphine equivalents


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: From 1 to 72 hours post surgery ]
    Measurement of pain score post-cesarian section will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain. Thus, higher values indicate a worse outcome.

  2. Ambulation Attempts [ Time Frame: From 1 to 72 hours post surgery ]
    Measurement of number of times patient ambulates post op

  3. Oral Intake [ Time Frame: From 1 to 24 hours post surgery ]
    Time to first oral intake

  4. Postoperative Nausea and Vomiting [ Time Frame: From 1 to 72 hours post surgery ]
    Treatment for postoperative nausea and vomiting

  5. Readmission rates [ Time Frame: Up to 21 days post surgery ]
    Readmissions to the hospital

  6. Foley catheter removal [ Time Frame: From 1 to 24 hours post surgery ]
    Time to Foley catheter removal postoperative

  7. Postoperative temperature [ Time Frame: 1 hour post surgery ]
    Temperature recorded in post-anesthesia care unit

  8. Hospital length of stay [ Time Frame: Time of admission until time of discharge, generally not over one week ]
    Length of stay in hospital post-cesarian



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on gender identity
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, MFM, OBCC.
Criteria

Inclusion Criteria:

Any patient 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, Maternal Fetal Medicine (MFM), Obstetrics Complications Clinic (OBCC).

Exclusion Criteria:

  1. Age less than 18 years old;
  2. urgent or emergent cesarean delivery;
  3. diagnosis of preeclampsia;
  4. coagulopathy that contraindicates neuraxial block placement;
  5. abnormal placentation;
  6. opioid abuse disorder;
  7. type C diabetic or greater.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552822


Contacts
Layout table for location contacts
Contact: Adam Sturdivant, MPH 205-934-4042 Adamsturdivant@uabmc.edu
Contact: Ayesha Bryant, MD 205-996-7383 asbryant@uabmc.edu

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Adam Sturdivant, MPH    205-934-4042    Adamsturdivant@uabmc.edu   
Principal Investigator: Mark Powell, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Study Chair: Sara A Lester, MD UAB Department of Anesthesiology, Critical Care Division

Layout table for additonal information
Responsible Party: Mark Powell, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03552822    
Other Study ID Numbers: 45678910
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No