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.
Brief Title
Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Detailed 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cesarean Section
Eligibility Criteria
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
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
Inclusion Criteria
Inclusion Criteria:
1. Women undergoing a non-urgent or elective cesarean delivery \>37 weeks gestation
1. Women undergoing a non-urgent or elective cesarean delivery \>37 weeks gestation
Gender
Female
Gender Based
false
Keywords
Enhanced Recovery
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02956616
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6966
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Primary Outcomes
Outcome Description
Number of patients discharged on postoperative Day #2
Outcome Measure
Discharge on Postoperative Day #2
Outcome Time Frame
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Secondary Outcomes
Outcome Description
The amount of postoperative pain medication required for each patient in Morphine Milligram Equivalents
Outcome Time Frame
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Outcome Measure
Postoperative Pain Medication Requirement
Outcome Description
All patients will be queried regarding whether breastfeeding was initiated after cesarean birth and how soon after birth
Outcome Time Frame
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Outcome Measure
Breastfeeding Initiation
Outcome Description
Postoperative Length of Hospital Stay in Hours from time of surgery
Outcome Time Frame
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Outcome Measure
Postoperative Length of Hospital Stay
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Peter Bernstein
Investigator Email
pbernste@montefiore.org
Investigator Phone