Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay (ERAC)

April 4, 2019 updated by: Peter S. Bernstein, Montefiore Medical Center
To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesize that an enhanced recovery program which includes several evidence based interventions at the time of cesarean birth in obstetrics will promote early ambulation, resumption of diet and initiation of breastfeeding, and reduce postoperative hospital length of stay.

Enhanced Recovery Protocol Components:

  1. Provide preoperative education about the perioperative recovery experience including postoperative analgesia, thromboprophylaxis and breastfeeding education

  2. Minimize preoperative starvation times

    1. Moderate amount of clears up to 2 hours prior to anesthesia
    2. Solid foods up to 6-8 hours prior to anesthesia
  3. Prophylactic antibiotics
  4. Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean birth and continued postoperatively
  5. Chewing gum (Xylitol) to reduce postoperative ileus
  6. Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac, 15mg every hour for 24 hours postoperatively to minimize postoperative narcotic use
  7. Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular diet as tolerated
  8. Early removal of urinary catheter (12 hours postoperatively)
  9. Early removal of dressing (6 hours postoperatively)
  10. Early mobilization at 12 hours after delivery
  11. Early skin-to- skin/breastfeeding initiation
  12. Early incentive spirometry

Currently, patients are encouraged to ambulate on the first post-operative day, but it is largely left up to the patient when to actually begin to ambulate. They are similarly offered a diet on the first postoperative day but are not encouraged to eat. Breastfeeding is more systematically encouraged early as part of Montefiore's effort to get baby friendly designation. And finally, patients are typically discharged on postoperative day number three unless complications arise in the newborn or the mother. As part of this study, patients in both the enhanced recovery and usual care group will be offered the opportunity to be discharged from the hospital on postoperative day number 2 if their recovery is progressing well and if they choose not to leave then they will be encouraged to return home on postoperative day number 3 according to the current standard of care.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation

Exclusion Criteria:

  1. Women undergoing an urgent or emergent cesarean birth
  2. Women less than 18 years old
  3. Patients receiving general anesthesia
  4. Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss (Placenta accreta)
  5. Pre-existing essential hypertension or hypertensive disorders of pregnancy (preeclampsia, eclampsia, HELLP)
  6. Chronic or acute renal impairment
  7. Bleeding disorders or platelet dysfunction
  8. Peptic ulcer disease or gastrointestinal bleeding
  9. Known hypersensitivity to ketorolac (toradol)
  10. Active infection at the time of cesarean
  11. Cesarean birth prior to 37 weeks
  12. Women in significant pain in labor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Recovery
Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.
Drug: ketorolac
Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.
Other Names:
  • Toradol
Other: Chewing Gum
Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function.
Other Names:
  • Xylitol
Procedure: Enhanced Recovery Protocol
enhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.
Active Comparator: Routine Perioperative Care
Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control
Drug: ketorolac
Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge on Postoperative Day #2
Time Frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Number of patients discharged on postoperative Day #2
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Medication Requirement
Time Frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
The amount of postoperative pain medication required for each patient in Morphine Milligram Equivalents
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Breastfeeding Initiation
Time Frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
All patients will be queried regarding whether breastfeeding was initiated after cesarean birth and how soon after birth
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Postoperative Length of Hospital Stay
Time Frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Postoperative Length of Hospital Stay in Hours from time of surgery
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-6966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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