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Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care

Women's First Gastrointestinal Activation Post-elective Cesarean Birth During Post-partum Hospitalization:A Comparison of Paula Method (the Circular Exercises Method) to Standard Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03761147
Enrollment
64
Registered
2018-12-03
Start date
2018-02-01
Completion date
2018-12-01
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Dysfunction

Brief summary

Women generally report discomfort and a delay in GI motility after CS. The Paula method, circular exercises of ring muscles has been shown to increase GI motility. This method had not been studied in women post CS. The current study is comparing the resumption of bowel sounds after CS in women utilizing the Paula exercises to standard care (no exercises).

Interventions

OTHERPaula exercises

structured exercises aimed to stimulate ring muscles

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Elective, singleton, term CS, with spinal or epidural anesthesia

Exclusion criteria

* GI/ absorption disorders (Chron's, IBS) * general anesthesia * urgent CS

Design outcomes

Primary

MeasureTime frameDescription
Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage72 hoursflatus passage

Countries

Israel

Participant flow

Participants by arm

ArmCount
Paula Method
Paula exercises: structured exercises aimed to stimulate ring muscles
32
Standard of Care
Standard of Care
32
Total64

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event13
Overall StudyWithdrawal by Subject61

Baseline characteristics

CharacteristicPaula MethodStandard of CareTotal
Age, Continuous35.65 years
STANDARD_DEVIATION 6.32
34.62 years
STANDARD_DEVIATION 5.15
35.14 years
STANDARD_DEVIATION 5.75
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
32 Participants32 Participants64 Participants
Region of Enrollment
Israel
32 participants32 participants64 participants
Sex: Female, Male
Female
32 Participants32 Participants64 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 320 / 32
other
Total, other adverse events
0 / 320 / 32
serious
Total, serious adverse events
0 / 320 / 32

Outcome results

Primary

Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage

flatus passage

Time frame: 72 hours

ArmMeasureValue (MEAN)Dispersion
Paula MethodTime to the Resumption of Bowel Functioning as Assessed by Flatus Passage24.1 hoursStandard Deviation 6.85
Standard of CareTime to the Resumption of Bowel Functioning as Assessed by Flatus Passage39.1 hoursStandard Deviation 10.4
p-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026