Back to resultsGastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care
Primary Purpose
Bowel Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Paula exercises
Sponsored by
About this trial
This is an interventional treatment trial for Bowel Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Elective, singleton, term CS, with spinal or epidural anesthesia
Exclusion Criteria:
- GI/ absorption disorders (Chron's, IBS)
- general anesthesia
- urgent CS
Sites / Locations
- Hadassah Medical Organization, Jerusalem, Israel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Paula Method
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage
flatus passage
Secondary Outcome Measures
Full Information
NCT ID
NCT03761147
First Posted
November 26, 2017
Last Updated
August 21, 2021
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT03761147
Brief Title
Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paula Method
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Paula exercises
Intervention Description
structured exercises aimed to stimulate ring muscles
Primary Outcome Measure Information:
Title
Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage
Description
flatus passage
Time Frame
72 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Elective, singleton, term CS, with spinal or epidural anesthesia
Exclusion Criteria:
GI/ absorption disorders (Chron's, IBS)
general anesthesia
urgent CS
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33249611
Citation
Liebergall-Wischnitzer M, Shaphir A, Solnica A, Hochner-Celnikier D. Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial. J Adv Nurs. 2021 Apr;77(4):2026-2032. doi: 10.1111/jan.14681. Epub 2020 Nov 29. Erratum In: J Adv Nurs. 2021 Nov;77(11):4598.
Results Reference
result
Learn more about this trial
Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care
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