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

Bowel Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761147
• Other study ID #: GI PAULA-HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2020
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 1, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• GI/ absorption disorders (Chron's, IBS)

• general anesthesia

• urgent CS

Related Conditions & MeSH terms

• Bowel Dysfunction
• Intestinal Diseases

Intervention

Other:
• Paula exercises
structured exercises aimed to stimulate ring muscles

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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/ja — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage	flatus passage	72 hours