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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT03761147
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 6.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Bowel Dysfunction	Other: Paula exercises	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 1, 2018
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paula Method	Other: Paula exercises; structured exercises aimed to stimulate ring muscles
No Intervention: Standard of Care

Outcome Measures

Primary Outcome Measures

1. Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage [72 hours]

   flatus passage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 7, 2017

More Information

Publications

None provided.

• Responsible Party: Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT03761147
• Other Study ID Numbers: GI PAULA-HMO-CTIL
• First Posted: Dec 3, 2018
• Last Update Posted: Sep 20, 2021
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Intestinal Diseases

Study Results

Participant Flow

Arm/Group Title	Paula Method	Standard of Care
Arm/Group Description	Paula exercises: structured exercises aimed to stimulate ring muscles	Standard of Care
Period Title: Overall Study
STARTED	32	32
COMPLETED	25	28
NOT COMPLETED	7	4

Baseline Characteristics

Arm/Group Title	Paula Method	Standard of Care	Total
Arm/Group Description	Paula exercises: structured exercises aimed to stimulate ring muscles	Standard of Care	Total of all reporting groups
Overall Participants	32	32	64
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.65 (6.32)	34.62 (5.15)	35.14 (5.75)
Sex: Female, Male (Count of Participants)
Female	32 100%	32 100%	64 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	32 100%	32 100%	64 100%
Region of Enrollment (participants) [Number]
Israel	32 100%	32 100%	64 100%

Outcome Measures

1. Primary Outcome

Title	Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage
Description	flatus passage
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paula Method	Standard of Care
Arm/Group Description	Paula exercises: structured exercises aimed to stimulate ring muscles	Standard of Care
Measure Participants	25	28
Mean (Standard Deviation) [hours]	24.1 (6.85)	39.1 (10.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paula Method, Standard of Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	96 hours
Arm/Group Title	Paula Method		Standard of Care
Arm/Group Description	Paula exercises: structured exercises aimed to stimulate ring muscles		Standard of Care
All Cause Mortality
	Paula Method		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Serious Adverse Events
	Paula Method		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Paula Method		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.