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

NCT02956616 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2016-6966
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

Enhanced Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative Pain Medication Requirement

  Until patient's day of hospital discharge or a maximum of one month from cesarean delivery

• Breastfeeding Initiation

  Until patient's day of hospital discharge or a maximum of one month from cesarean delivery

• Postoperative Length of Hospital Stay

  Until patient's day of hospital discharge or a maximum of one month from cesarean delivery

Study Arms (2)

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.

Drug: ketorolac; Other: Chewing Gum; Procedure: Enhanced Recovery Protocol

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

Drug: ketorolac

Interventions

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.

Also known as: Toradol

Enhanced Recovery; Routine Perioperative Care

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.

Also known as: Xylitol

Enhanced Recovery

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.

Enhanced Recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (16)

• 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.

  PMID: 25794417 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.

  PMID: 7936522 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.

  PMID: 26580836 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.

  PMID: 23635626 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.

  PMID: 24856433 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.

  PMID: 25754213 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.

  PMID: 25457588 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.

  PMID: 26479169 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.

  PMID: 24628729 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.

  PMID: 24629205 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.

  PMID: 20013603 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.

  PMID: 27018465 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.

  PMID: 14710063 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.

  PMID: 25145762 BACKGROUND

• 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.

  PMID: 21236454 RESULT

• 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.

  PMID: 31669738 DERIVED

MeSH Terms

Interventions

Ketorolac; Ketorolac Tromethamine; Chewing Gum; Xylitol

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sugar Alcohols; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Peter S. Bernstein, MD, MPH
• Organization: Montefiore Medical Center

pbernste@montefiore.org

718-904-2767

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 7, 2016
• Study Start: September 1, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: April 25, 2019
• Results First Posted: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)