Montefiore Medical Center
The Bronx, New York, 10467, United States
NCT Number: NCT02956616
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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Female
Interventional
Phase 2
The Bronx, New York, 10467, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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 (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.
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
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
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
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
Montefiore Medical Center
Other
Acronym: ERAC
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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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