Clinical trial NCT02956616: Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Official title: Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cesarean Section
Keywords: Enhanced Recovery
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Discharge on Postoperative Day #2
timeFrame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Secondary outcomes:
measure: Postoperative Pain Medication Requirement
timeFrame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
measure: Breastfeeding Initiation
timeFrame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
measure: Postoperative Length of Hospital Stay
timeFrame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
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