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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.
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:
Provide preoperative education about the perioperative recovery experience including postoperative analgesia, thromboprophylaxis and breastfeeding education
Minimize preoperative starvation times
Prophylactic antibiotics
Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean birth and continued postoperatively
Chewing gum (Xylitol) to reduce postoperative ileus
Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac, 15mg every hour for 24 hours postoperatively to minimize postoperative narcotic use
Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular diet as tolerated
Early removal of urinary catheter (12 hours postoperatively)
Early removal of dressing (6 hours postoperatively)
Early mobilization at 12 hours after delivery
Early skin-to- skin/breastfeeding initiation
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Recovery | Experimental | 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. |
|
| Routine Perioperative Care | Active Comparator | Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketorolac | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge on Postoperative Day #2 | Number of patients discharged on postoperative Day #2 | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Medication Requirement | 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 |
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Inclusion Criteria:
1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25794417 | Background | Wrench IJ, Allison A, Galimberti A, Radley S, Wilson MJ. Introduction of enhanced recovery for elective caesarean section enabling next day discharge: a tertiary centre experience. Int J Obstet Anesth. 2015 May;24(2):124-30. doi: 10.1016/j.ijoa.2015.01.003. Epub 2015 Jan 14. | |
| 7936522 | Background | Brooten D, Roncoli M, Finkler S, Arnold L, Cohen A, Mennuti M. A randomized trial of early hospital discharge and home follow-up of women having cesarean birth. Obstet Gynecol. 1994 Nov;84(5):832-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for |
| FG001 | 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Discharge on Postoperative Day #2 | Number of patients discharged on postoperative Day #2 | Posted | Count of Participants | Participants | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery |
|
Throughout the duration of study from enrollment until 6 weeks after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter S. Bernstein, MD, MPH | Montefiore Medical Center | 718-904-2767 | pbernste@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2017 | Feb 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D002638 | Chewing Gum |
| D014993 | Xylitol |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
|
| Chewing Gum | Other | 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. |
|
|
| Enhanced Recovery Protocol | Procedure | 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. |
|
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 | 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 |
| 26580836 | Background | Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available. |
| 23635626 | Background | Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee. |
| 24856433 | Background | Masood SN, Masood Y, Naim U, Masood MF. A randomized comparative trial of early initiation of oral maternal feeding versus conventional oral feeding after cesarean delivery. Int J Gynaecol Obstet. 2014 Aug;126(2):115-9. doi: 10.1016/j.ijgo.2014.02.023. Epub 2014 Apr 29. |
| 25754213 | Background | Huang H, Wang H, He M. Early oral feeding compared with delayed oral feeding after cesarean section: a meta-analysis. J Matern Fetal Neonatal Med. 2016;29(3):423-9. doi: 10.3109/14767058.2014.1002765. Epub 2015 Mar 10. |
| 25457588 | Background | Guo J, Long S, Li H, Luo J, Han D, He T. Early versus delayed oral feeding for patients after cesarean. Int J Gynaecol Obstet. 2015 Feb;128(2):100-5. doi: 10.1016/j.ijgo.2014.07.039. Epub 2014 Oct 22. |
| 26479169 | Background | Saad AF, Saoud F, Diken ZM, Hegde S, Kuhlmann MJ, Wen TS, Hankins GD, Saade GR, Costantine MM. Early versus Late Feeding after Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2016 Mar;33(4):415-9. doi: 10.1055/s-0035-1565918. Epub 2015 Oct 19. |
| 24628729 | Background | Craciunas L, Sajid MS, Ahmed AS. Chewing gum in preventing postoperative ileus in women undergoing caesarean section: a systematic review and meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):793-9; discussion 799. doi: 10.1111/1471-0528.12696. Epub 2014 Mar 14. |
| 24629205 | Background | Zhu YP, Wang WJ, Zhang SL, Dai B, Ye DW. Effects of gum chewing on postoperative bowel motility after caesarean section: a meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):787-92. doi: 10.1111/1471-0528.12662. Epub 2014 Mar 14. |
| 20013603 | Background | Shang H, Yang Y, Tong X, Zhang L, Fang A, Hong L. Gum chewing slightly enhances early recovery from postoperative ileus after cesarean section: results of a prospective, randomized, controlled trial. Am J Perinatol. 2010 May;27(5):387-91. doi: 10.1055/s-0029-1243313. Epub 2009 Dec 11. |
| 27018465 | Background | Peleg D, Eberstark E, Warsof SL, Cohen N, Ben Shachar I. Early wound dressing removal after scheduled cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2016 Sep;215(3):388.e1-5. doi: 10.1016/j.ajog.2016.03.035. Epub 2016 Mar 25. |
| 14710063 | Background | Lowder JL, Shackelford DP, Holbert D, Beste TM. A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage. Am J Obstet Gynecol. 2003 Dec;189(6):1559-62; discussion 1562. doi: 10.1016/j.ajog.2003.08.014. |
| 25145762 | Background | El-Mazny A, El-Sharkawy M, Hassan A. A prospective randomized clinical trial comparing immediate versus delayed removal of urinary catheter following elective cesarean section. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:111-4. doi: 10.1016/j.ejogrb.2014.07.034. Epub 2014 Aug 1. |
| 21236454 | Result | Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14. |
| 31669738 | Derived | Teigen NC, Sahasrabudhe N, Doulaveris G, Xie X, Negassa A, Bernstein J, Bernstein PS. Enhanced recovery after surgery at cesarean delivery to reduce postoperative length of stay: a randomized controlled trial. Am J Obstet Gynecol. 2020 Apr;222(4):372.e1-372.e10. doi: 10.1016/j.ajog.2019.10.009. Epub 2019 Oct 26. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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 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. |
|
|
| Secondary | Postoperative Pain Medication Requirement | The amount of postoperative pain medication required for each patient in Morphine Milligram Equivalents | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery |
|
|
|
| Secondary | Breastfeeding Initiation | All patients will be queried regarding whether breastfeeding was initiated after cesarean birth and how soon after birth | Posted | Count of Participants | Participants | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery |
|
|
|
| Secondary | Postoperative Length of Hospital Stay | Postoperative Length of Hospital Stay in Hours from time of surgery | Posted | Median | Inter-Quartile Range | Hours | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 0 | 60 |
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| D006571 | Heterocyclic Compounds |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| Both Breastfeeding and Bottlefeeding |
|