Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03552822
Study type Observational
Source University of Alabama at Birmingham
Contact
Status Completed
Phase
Start date July 1, 2018
Completion date February 1, 2020

See also
  Status Clinical Trial Phase
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03631329 - Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Active, not recruiting NCT03760718 - Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery Early Phase 1
Active, not recruiting NCT04965779 - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women N/A
Terminated NCT01687972 - INSORB Versus Subcuticular Sutures at Cesarean Section Phase 1
Withdrawn NCT01211431 - Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine Phase 4
Completed NCT00987701 - Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors N/A
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Completed NCT01049477 - The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery N/A
Terminated NCT00524511 - Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples N/A
Completed NCT00375986 - A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Completed NCT00517140 - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function N/A
Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A