Conditions: Cesarean Section
Keywords: Enhanced Recovery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 118
Healthy volunteers: yes

Brief summary:
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.

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.

Arms:
arm 1: 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. arm 2: Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control

Interventions: intervention 1: ketorolac intervention 2: Chewing Gum intervention 3: Enhanced Recovery Protocol
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol document:
Prot_SAP_000.pdf: 
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IRB # 2016- 6966 
Title: A program of enhanced recovery after cesarean birth to improve postoperative 
recovery and reduce hospital length of stay
Study Contact Information
Principal Investigator 
Peter S. Bernstein, MD, MPH
Professor of Clinical Obstetrics & Gynecology and Women's Health
Montefiore Medical Center
Jack D. Weiler Hospital
1825 Eastchester Road
Bronx, NY 10461 USA
 
Telephone: 718-904-2767
email: pbernste@montefiore.org
Co-Investigator
Nickolas Teigen, MD                    
Maternal Fetal Medicine Fellow
Department of Obstetrics & Gynecology and Women’s Health
Montefiore Medical Center
Jack D. Weiler Hospital
1825 Eastchester Road
Bronx, NY 10461 USA
 
Telephone: 617-835-1032
Email: nteigen@montefiore.org
Background: Enhanced recovery after surgery (ERAS) involves changes to multiple aspects of 
perioperative care with the aim of standardizing postoperative patient care, improving patient 
outcomes, reducing postoperative length of stay, and optimizing patient satisfaction. Enhanced 
recovery pathways have been widely implemented in many different areas of surgery. Initially, 
these pathways were introduced in colorectal surgery nearly 15 years ago, but have found more 
widespread usage in specialties including urology, orthopedics, breast surgery and gynecologic 
surgery. Initiation of enhanced recovery programs have consistently resulted in reduced hospital 
length of stay, financial savings and improved patient satisfaction.1
To date, only one observational study in obstetrics has been performed looking at the 
introduction of an enhanced recovery pathway in the United Kingdom. In that study the 
investigators were able to successfully introduce an enhanced recovery program to their 
obstetrics unit and noted a greater proportion of patients discharged earlier with improved 
patient satisfaction, without a concomitant increase in readmission rates.2  
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The components of enhanced recovery pathways vary significantly, though all seek to provide 
benefit to the patient by optimizing the postoperative recovery course through the combination 
of multiple evidence-based practices. In previous studies aimed at post-cesarean birth 
discharge timing, comparing early versus usual discharge time, there was no difference 
observed in the number of maternal readmissions, maternal antibiotic use, maternal well-being 
and anxiety or depression.3 
Components of enhanced recovery pathways can include standardizing the use of prophylactic 
antibiotics, venous thromboembolism prophylaxis, minimizing starvation times, use of 
antiemetics, earlier resumption of feeding postoperatively, use of chewing gum postoperatively, 
early removal of dressings and urinary catheters, and standing postoperative pain medication 
orders. Prophylactic antibiotics and venous thromboembolism prophylaxis are routinely 
recommended at the time of cesarean deliveries by the American Congress of Obstetricians 
and Gynecologists.4-5 In addition, the American Society of Anesthesiologists recommends 
minimizing preoperative starvation times with moderate amounts of clear liquids up to 2 hours 
prior to induction of anesthesia and solid foods up to 6-8 hours preoperatively.6 Routine 
administration of antiemetics at the time of cesarean to reduce early postoperative nausea and 
vomiting may allow earlier resumption of feeding after cesarean.7 Several studies have 
determined that early resumption of feeding after cesarean resulted in early ambulation, greater 
maternal satisfaction, and reduced length of hospital stay, with no detrimental outcomes.8-12 
Moreover, the introduction of chewing gum postoperatively has resulted in a reduction in 
postoperative ileus after cesarean.13-15
A recent randomized controlled trial evaluating the early removal of wound dressings at 6 hours 
postoperatively, noted there was no detrimental effect on incision healing with early removal 
permitting earlier attention to personal hygiene with greater patient satisfaction.16 Additionally, a 
randomized controlled trial of Ketorolac use at cesarean birth resulted in reduced postoperative 
pain and narcotic use.17 Early removal of urinary catheters postoperatively were also associated 
with a lower risk of infection and earlier postoperative ambulation.18
Currently, no randomized studies exist in the literature specifically addressing the potential 
impact of an enhanced recovery pathway in among women undergoing cesarean births on 
postoperative outcomes and postoperative length of stay in the United States. We aim to 
implement an enhanced recovery pathway at the time of cesarean birth to expedite the 
postoperative recovery process, thereby reducing postoperative hospital length of stay.
Hypothesis: We hypothesize that an enhanced recovery program 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.
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.
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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 going 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.
Null hypothesis: An enhanced recovery program at the time of cesarean birth will have no 
impact on postoperative hospital length of stay (our primary outcome variable).
Objective: To determine whether women randomized to an enhanced recovery program will 
have improved postoperative outcomes, improved breastfeeding initiation and continuation, 
reduction in hospital length of stay without compromising patient satisfaction in comparison to 
standard of care postoperative recovery interventions. 
Materials and Methods: This will be a prospective non-blinded randomized controlled study of 
women presenting for care to the Montefiore Medical Center. All patients will undergo routine 
obstetrical care and preparation for cesarean birth as if they were not participating in the 
research study. Women participating in the study will be greater than 37 0/7 weeks gestation 
based on their estimated due date calculated from last menstrual period or early ultrasound. 
The women participating in the study will be undergoing either: 1. Scheduled cesarean birth or 
2. Non-emergent cesarean birth. Non-emergent cesarean birth will be defined as an indicated 
cesarean birth based on obstetrical criteria without significant fetal heart tracing abnormalities. 
This would include women diagnosed with a labor dystocia or arrest of labor, failed labor 
induction, fetal malpresentation in labor (i.e. breech presentation) or any other non-emergent 
indication for cesarean birth in which there is no immediate danger to mother or fetus. Patient 
consent will occur on admission to the obstetrical labor and delivery unit for elective cesarean 
births. Because patients presenting to our units may be in pain and pain may compromise 
cognition and judgment, at the time of actual enrollment, the principal investigator or his or her 
designee will assess the capacity of the patient to provide ethically and legally adequate 
informed consent and will document that finding in the research record. If at the time they are 
approached for actual involvement in the protocol, they are in too much pain to have the 
informed consent discussion and provide consent, they will not be considered for participation. 
Women that accept participation will be randomly assigned to an enhanced recovery program or 
routine perioperative care. Using a random sequence number table, we will generate block 
randomization. Allocations will be placed in sequentially numbered opaque sealed envelopes.
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, which will include 
several evidence based recommendations (see Enhanced Recovery Protocol components, 
below) including early ambulation, early diet initiation, early removal of urinary catheter, early 
removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.
Maternal demographics to be obtained will include body mass index (BMI), gestational age, pre-
operative and post-operative day #1 complete blood count, estimated blood loss, surgical time 
from skin incision to closure, skin closure method, birth weight, Apgar scores, newborn 
outcomes, indication for cesarean birth, medical history and any antenatal complications, past 
surgical history, postoperative course and intra-operative and post-operative complications.
All patients will be followed until the routine postpartum visit occurs at 6-8 weeks following 
cesarean birth. Postpartum visit information will be extracted from the medical record. The 
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patient will then be contacted by telephone at 8 weeks after cesarean birth and asked about her 
postoperative course regarding her overall satisfaction with her postoperative care and if any 
postoperative complications arose during the postpartum period.
A description of this clinical trial is available on www.ClinicalTrials.gov, as required by U.S.
law. The clinicaltrials.gov identifier for the study is NCT02956616.
Enhanced Recovery Protocol Components:
1.
Provide preoperative education about the perioperative recovery experience including 
postoperative analgesia, thromboprophylaxis and breastfeeding education - Patients will 
be provided with standardized printed instructions for the perioperative experience
2.
Minimize preoperative starvation times
a.
Moderate amount of clears up to 2 hours prior to anesthesia - patients will be 
encouraged to consume a moderate amount of clear liquid diet up to 2 hours 
prior to anesthesia.
b.
Solid foods up to 6-8 hours prior to anesthesia - solid foods will be encouraged 
up to 6-8 hours preoperatively, in contrast to the current practice of all patients 
limiting food intake after midnight the day of surgery.
3.
Prophylactic antibiotics - currently offered as the standard of care to all patients 
undergoing cesarean birth, based on recommendations from the American Congress of 
Obstetricians and Gynecologists
4.
Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean 
birth and continued postoperatively - currently offered as the standard of care at our 
institution with sequential compression devices at the time of cesarean birth and 
immediately postoperatively with provision of chemoprophylaxis with subcutaneous 
heparin after 24 hours from the time of the procedure
5.
Chewing gum (Xylitol) to reduce postoperative ileus - 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.
6.
Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac (toradol), 
Intravenous 15mg every 6 hours for 24 hours postoperatively to minimize postoperative 
narcotic use. First dose will be provided 6 hours after procedure with 3 subsequent 
doses every 6 hours for a total of 4 doses over 24 hours.
7.
Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular 
diet as tolerated - This is in contrast to the current practice of limiting postoperative 
feeding until a minimum of 2 hours after cesarean birth once the patient has left the 
PACU
8.
Early removal of urinary catheter (12 hours postoperatively) - An order will be placed at 
the completion of the procedure to discontinue the urinary catheter 12 hours 
postoperatively
9.
Early removal of dressing (6 hours postoperatively) - An order will be placed at the 
completion of the procedure to instruct removal of the postoperative dressing at 6 hours 
postoperatively
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10. Early mobilization at 12 hours after cesarean birth - An order will be placed at the 
completion of the procedure to encourage patients to begin ambulating 12 hours after 
the cesarean birth
11. Early skin-to-skin/breastfeeding initiation - this is the standard of care at our institution in 
which skin-to-skin contact and breastfeeding are initiated as soon as possible in the 
operating room or PACU
12. Early incentive spirometry - An order will be placed at the completion of the procedure to 
provide an incentive spirometer and patients will be encouraged immediately following 
the surgical procedure in the postoperative anesthesia care unit
Routine Recovery Protocol Components (control group):
1.
Oral intake prior to procedure – patients will be required to limit food intake to at least 8 
hours prior to the cesarean birth or after midnight the day of the procedure as is current 
standard of practice
2.
Prophylactic antibiotics - currently offered as the standard of care to all patients 
undergoing cesarean birth, based on recommendations from the American Congress of 
Obstetricians and Gynecologists
3.
Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean 
birth and continued postoperatively - currently offered as the standard of care at our 
institution with sequential compression devices at the time of cesarean birth and 
immediately postoperatively with provision of chemoprophylaxis with subcutaneous 
heparin after 24 hours from the time of the procedure
4.
Patients will be provided with routine regional anesthetic per current anesthesia protocol
5.
Patients are currently offered non-steroidal anti-inflammatory (Ibuprofen) and Percocet 
on an as needed basis for pain control postoperatively
6.
Patients will be provided with a meal as early as 2 hours postoperatively once the patient 
has been transferred from the postoperative anesthesia care unit
7.
Urinary catheter will be removed on postoperative day #1 as is the current standard of 
practice in our institution
8.
Wound dressings will be removed on postoperative day #1 as is the current standard of 
practice in our institution
9.
Patients will mobilize once sensation and motor function of the lower extremities returns
10. Early skin-to-skin/breastfeeding initiation - this is the standard of care at our institution in 
which skin-to-skin contact and breastfeeding are initiated as soon as possible in the 
operating room or PACU
11. Patients will be provided with an incentive spirometer once they arrive on the postpartum 
unit which is the current standard of practice in our institution.
12. Control group participants may receive IV ketorolac for pain control
Primary Outcome:
1.
Postoperative length of hospital stay
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Secondary Outcomes:
1.
Postoperative pain medication requirements
2.
Breastfeeding initiation and continuation rates
3.
Patient satisfaction
4.
Maternal-neonatal bonding
5.
Time to ambulation
6.
Time to resumption of normal activity
7.
Time to attempting oral feeding
8.
Total length of hospital stay
9.
Postoperative infections from expedited removal of catheter versus removal of wound 
dressing
10. Readmission rates
11. Postpartum depression/anxiety
Inclusion criteria:
1.
Women undergoing a non-urgent or elective cesarean birth >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 accrete)
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
Sites: Montefiore Medical Center (Both Weiler and Wakefield on their labor floors)
Study size and Power: Patients are routinely discharged on postoperative day number 3 or 
approximately 72 hours postoperatively at Montefiore Medical Center following cesarean birth. 
Our primary outcome variable will be postoperative length of hospital stay. Patients in the 
routine perioperative care group and the enhanced recovery protocol group will be offered the 
opportunity to be discharged on postoperative day number 2 or approximately 48 hours 
postoperatively at the discretion of the obstetric attending physician. Our experience is that no 
more than 10% of patients are discharged home on postoperative day number 2 or 
approximately 48 hours postoperatively. We therefore have calculated that if we anticipate an 
increase in the rate of early discharges on postoperative day number 2 from 10% to 30% with 
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the enhanced recovery pathway will require 59 subjects in each group, and 118 total 
participants, with an alpha error of 0.05 and a power of 80%. Patients in the control group will 
continue to be offered Ketorolac for postoperative analgesia which is considered standard of 
care in our institution. Approximately 65 percent of patients after cesarean deliveries from a 
recent chart review receive ketorolac of at least one dose. Given that our primary outcome 
measure is postoperative length of stay, and patients receiving ketorolac at present still routinely 
are discharged on postoperative day number 3, we do not anticipate that this will produce a 
contamination factor with respect to our primary outcome measure which is postoperative length 
of stay. As a result, our power calculation would therefore still remain valid for our primary 
outcome measure.
Risks/Benefits:
 
Ketorolac tromethamine, including Toradol can cause peptic ulcers, gastrointestinal bleeding 
and/or perforation of the stomach or intestines, which can be fatal. These events can occur at 
any time during use and without warning symptoms. Ketorolac is contraindicated in patients with 
active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in 
patients with a history of peptic ulcer disease or gastrointestinal bleeding. NSAIDs may cause 
an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, 
which can be fatal. This risk may increase with duration of use. Patients with cardiovascular 
disease or risk factors for cardiovascular disease may be at greater risk Ketorolac is 
contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass 
graft surgery. Ketorolac is contraindicated in patients with advanced renal impairment and in 
patients at risk for renal failure due to volume depletion. Toradol inhibits platelet function and is, 
therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, 
patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding 
 
Limited data from one published study involving 10 breastfeeding women 2-6 days postpartum 
showed low levels of ketorolac in breast milk. Levels were undetectable (less than 5 ng/mL) in 4 
of the patients. After a single administration of 10 mg of Ketorolac, the maximum milk 
concentration observed was 7.3 ng/mL, and the maximum milk-to-plasma ratio was 0.037. After 
1 day of dosing (10 mg every 6 hours), the maximum milk concentration was 7.9 ng/mL, and the 
maximum milk-to-plasma ratio was 0.025. Assuming a daily intake of 400-1,000 mL of human 
milk per day and a maternal body weight of 60 kg, the calculated maximum daily infant 
exposure was 0.00263 mg/kg/day, which is 0.4% of the maternal weight-adjusted dose. 
Exercise caution when ketorolac is administered to a nursing woman. Available information has 
not shown any specific adverse events in nursing infants; however, instruct patients to contact 
their infant's health care provider if they note any adverse events. The American academy of 
pediatrics has found ketorolac to be compatible with breastfeeding.
There are no known risks to this study beyond that of routine postoperative care at the time of 
cesarean birth in addition to the aforementioned use of Ketorolac. All patient information will be 
kept confidential. Patient research records will be kept confidential and names will not be used 
in any written or verbal reports. The patient’s information will be given a code number and 
separated from your name or any other information that could identify them. All information will 
be kept in a secure manner and computer records will be password protected. Study information 
will be kept as long as they are useful for the completion of the research study after which they 
will be destroyed.
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The patient will not experience any direct benefit personally from participation in this study. The 
benefit of participation in this study will generate important information about improving 
postoperative recovery at cesarean birth.
Data Management: Data collected in this study protocol will be extracted from the secure 
password protected computer programs utilized by Montefiore for patient care: Epic / 
ASOBGYN/ EPFweb. Information extracted for study use will be maintained on a password 
protected computer in a locked office and not accessible to others. Once the clinical information 
obtained on a patient is completed the information will be de-identified. Patient confidentiality 
will be maintained at all times.
Statistics: To achieve comparable groups we will randomize enrollees to one of two treatment 
arms. Randomization will be done with block sizes of 4 to reduce the likelihood of unmasking 
the randomized assignment. Randomization will be done according to separate lists generated 
through www.randomization.com. Randomization will be performed by Dr. Catherine Igel. No 
patient identifying information will be entered into this website as this will be done prior to 
enrollment in the study
The primary aim of the study is to compare whether women randomized to an enhanced 
recovery program will have improved postoperative outcomes, breastfeeding initiation, reduction 
in length of stay without compromising patient satisfaction in comparison to standard of care 
postoperative recovery interventions. The primary analysis will be a chi-square comparison of 
proportions of the 2 x 2 table of study arm (experimental/control) and hospital length of stay 
(shortened length of stay/standard length of stay). We will also assess an odds ratio (with 95% 
confidence interval) for additional outcome measures: Postoperative pain medication 
requirements, Breastfeeding initiation and continuation rates and patient satisfaction will be 
determined by a follow-up survey performed greater than 4 weeks postoperatively.
Data safety monitoring Plan (DSMP): In order to maintain additional patient safety, a DSMP 
will be in place for the study. The data will be reviewed by two clinicians familiar with cesarean 
birth and perioperative and postoperative management and complications who are not part of 
the study, namely Dr. Rodney Wright and Dr. Ashlesha Dayal. In addition, a statistician who is 
not part of the study will review the data, Dr. Shankar Viswanathan. The Data safety monitoring 
committee will meet every 6 months. Minutes of the meetings including attendance, a summary 
of discussion and any relevant findings will be recorded. Data will be reviewed for adverse 
events throughout the study duration. The results of findings and recommendations of the team 
will be reported to the Albert Einstein College of Medicine institutional review board for review 
and action. 
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