Cesarean Section
Conditions
Keywords
Enhanced Recovery
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.
Interventions
DRUGketorolac
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.
OTHERChewing Gum
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.
PROCEDUREEnhanced Recovery Protocol
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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge on Postoperative Day #2 | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Medication Requirement | 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 |
| Breastfeeding Initiation | 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 |
| Postoperative Length of Hospital Stay | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Recovery 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. | 58 |
| Routine Perioperative Care Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control. | 60 |
| Total | 118 |
Baseline characteristics
| Characteristic | Enhanced Recovery | Routine Perioperative Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 60 Participants | 118 Participants |
| Age, Continuous | 30.43 years STANDARD_DEVIATION 4.92 | 31.93 years STANDARD_DEVIATION 5.43 | 31.18 years STANDARD_DEVIATION 5.17 |
| Race/Ethnicity, Customized African American | 13 Participants | 16 Participants | 29 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 33 Participants | 29 Participants | 62 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Female | 58 Participants | 60 Participants | 118 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 60 |
| other Total, other adverse events | 0 / 58 | 0 / 60 |
| serious Total, serious adverse events | 0 / 58 | 0 / 60 |
Outcome results
Primary
Discharge on Postoperative Day #2
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Recovery | Discharge on Postoperative Day #2 | 5 Participants |
| Routine Perioperative Care | Discharge on Postoperative Day #2 | 2 Participants |
Secondary
Breastfeeding Initiation
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Recovery | Breastfeeding Initiation | Breastfeeding | 39 Participants |
| Enhanced Recovery | Breastfeeding Initiation | Bottlefeeding | 4 Participants |
| Enhanced Recovery | Breastfeeding Initiation | Both Breastfeeding and Bottlefeeding | 15 Participants |
| Routine Perioperative Care | Breastfeeding Initiation | Breastfeeding | 29 Participants |
| Routine Perioperative Care | Breastfeeding Initiation | Bottlefeeding | 2 Participants |
| Routine Perioperative Care | Breastfeeding Initiation | Both Breastfeeding and Bottlefeeding | 29 Participants |
Secondary
Postoperative Length of Hospital Stay
Postoperative Length of Hospital Stay in Hours from time of surgery
Time frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Recovery | Postoperative Length of Hospital Stay | 73.58 Hours |
| Routine Perioperative Care | Postoperative Length of Hospital Stay | 75.50 Hours |
Secondary
Postoperative Pain Medication Requirement
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Recovery | Postoperative Pain Medication Requirement | 117.16 Morphine Milligram Equivalents | Standard Deviation 54.17 |
| Routine Perioperative Care | Postoperative Pain Medication Requirement | 119.38 Morphine Milligram Equivalents | Standard Deviation 47.98 |