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

Cesarean Section Clinical Trial

— ERAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956616
• Other study ID #: 2016-6966
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: April 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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:
• 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.

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (15)

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/ — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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):615-23. doi: 10.1097/AOG.0b013e3182839fee. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Breastfeeding Initiation	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
Secondary	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