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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03761147
Other study ID # GI PAULA-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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