Trial Outcomes & Findings for Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care (NCT NCT03761147)
NCT ID: NCT03761147
Last Updated: 2021-09-20
Results Overview
flatus passage
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
72 hours
Results posted on
2021-09-20
Participant Flow
Participant milestones
| Measure |
Paula Method
Paula exercises: structured exercises aimed to stimulate ring muscles
|
Standard of Care
Standard of Care
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
25
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Paula Method
Paula exercises: structured exercises aimed to stimulate ring muscles
|
Standard of Care
Standard of Care
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Adverse Event
|
1
|
3
|
Baseline Characteristics
Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care
Baseline characteristics by cohort
| Measure |
Paula Method
n=32 Participants
Paula exercises: structured exercises aimed to stimulate ring muscles
|
Standard of Care
n=32 Participants
Standard of Care
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.65 years
STANDARD_DEVIATION 6.32 • n=99 Participants
|
34.62 years
STANDARD_DEVIATION 5.15 • n=107 Participants
|
35.14 years
STANDARD_DEVIATION 5.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
32 participants
n=99 Participants
|
32 participants
n=107 Participants
|
64 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 hoursflatus passage
Outcome measures
| Measure |
Paula Method
n=25 Participants
Paula exercises: structured exercises aimed to stimulate ring muscles
|
Standard of Care
n=28 Participants
Standard of Care
|
|---|---|---|
|
Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage
|
24.1 hours
Standard Deviation 6.85
|
39.1 hours
Standard Deviation 10.4
|
Adverse Events
Paula Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of 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