NCT03761147

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 12, 2021

Completed
Last Updated

September 20, 2021

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

November 26, 2017

Results QC Date

August 19, 2019

Last Update Submit

August 21, 2021

Conditions

Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

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

    flatus passage

    72 hours

Study Arms (2)

Paula Method

EXPERIMENTAL
Other: Paula exercises

Standard of Care

NO INTERVENTION

Interventions

Paula exercisesOTHER

structured exercises aimed to stimulate ring muscles

Paula Method

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

Related 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/jan.14681. Epub 2020 Nov 29.

    PMID: 33249611RESULT

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Anna Shaphir
Organization
Hebrew Univeristy
shaphira@hadassah.org.il
+972 50 716 7309

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 3, 2018

Study Start

February 1, 2018

Primary Completion

July 31, 2018

Study Completion

December 1, 2018

Last Updated

September 20, 2021

Results First Posted

August 12, 2021

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)