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OpenTrials
Completed

NCT Number: NCT02956616

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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
  • Moderate amount of clears up to 2 hours prior to anesthesia
  • Solid foods up to 6-8 hours prior to anesthesia
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Toradol

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.

Other names: Xylitol

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Acronym: ERAC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2016
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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