Trial Outcomes & Findings for Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay (NCT NCT02956616)
NCT ID: NCT02956616
Last Updated: 2019-04-25
Results Overview
Number of patients discharged on postoperative Day #2
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Results posted on
2019-04-25
Participant Flow
Participant milestones
| Measure |
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.
ketorolac: 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.
Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for
|
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
ketorolac: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
|
Overall Study
COMPLETED
|
58
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Baseline characteristics by cohort
| Measure |
Enhanced Recovery
n=58 Participants
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.
|
Routine Perioperative Care
n=60 Participants
Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30.43 years
STANDARD_DEVIATION 4.92 • n=99 Participants
|
31.93 years
STANDARD_DEVIATION 5.43 • n=107 Participants
|
31.18 years
STANDARD_DEVIATION 5.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Until patient's day of hospital discharge or a maximum of one month from cesarean deliveryNumber of patients discharged on postoperative Day #2
Outcome measures
| Measure |
Enhanced Recovery
n=58 Participants
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.
ketorolac: 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.
Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for
|
Routine Perioperative Care
n=60 Participants
Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control
ketorolac: 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.
|
|---|---|---|
|
Discharge on Postoperative Day #2
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Until patient's day of hospital discharge or a maximum of one month from cesarean deliveryThe amount of postoperative pain medication required for each patient in Morphine Milligram Equivalents
Outcome measures
| Measure |
Enhanced Recovery
n=58 Participants
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.
ketorolac: 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.
Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for
|
Routine Perioperative Care
n=60 Participants
Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control
ketorolac: 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.
|
|---|---|---|
|
Postoperative Pain Medication Requirement
|
117.16 Morphine Milligram Equivalents
Standard Deviation 54.17
|
119.38 Morphine Milligram Equivalents
Standard Deviation 47.98
|
SECONDARY outcome
Timeframe: Until patient's day of hospital discharge or a maximum of one month from cesarean deliveryAll patients will be queried regarding whether breastfeeding was initiated after cesarean birth and how soon after birth
Outcome measures
| Measure |
Enhanced Recovery
n=58 Participants
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.
ketorolac: 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.
Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for
|
Routine Perioperative Care
n=60 Participants
Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control
ketorolac: 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.
|
|---|---|---|
|
Breastfeeding Initiation
Breastfeeding
|
39 Participants
|
29 Participants
|
|
Breastfeeding Initiation
Bottlefeeding
|
4 Participants
|
2 Participants
|
|
Breastfeeding Initiation
Both Breastfeeding and Bottlefeeding
|
15 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Until patient's day of hospital discharge or a maximum of one month from cesarean deliveryPostoperative Length of Hospital Stay in Hours from time of surgery
Outcome measures
| Measure |
Enhanced Recovery
n=58 Participants
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.
ketorolac: 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.
Chewing Gum: Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for
|
Routine Perioperative Care
n=60 Participants
Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control
ketorolac: 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.
|
|---|---|---|
|
Postoperative Length of Hospital Stay
|
73.58 Hours
Interval 71.08 to 76.62
|
75.50 Hours
Interval 72.86 to 76.84
|
Adverse Events
Enhanced Recovery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Perioperative Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place