Paula Method Versus Chewing Gum for Postoperative Recovery After Caesarean Section

September 21, 2023 updated by: Joshua Rosenbloom, Hadassah Medical Organization

Comparing Effectiveness of Paula Method Versus Chewing Gum for Postoperative Recovery of Gastrointestinal Function in Patients After Elective Caesarean Section

The goal of this clinical trial is to compare the effectiveness of gum chewing vs Paula exercises in patients after cesarean delivery. The main question it aims to answer is: does the Paula method hasten the time to recovery of bowel function compared to gum chewing after cesarean delivery.

Participants will be asked to either chew gum or to do Paula exercises. The time to restoration of bowel function after the surgery will be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women after an elective caesarean delivery
  • Age 18+
  • Ability to read and write in Hebrew

Exclusion Criteria:

  • Diagnosis of chronic gastrointestinal diseases
  • Inability to chew gum
  • Use of laxatives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paula
The patients will perform Paula exercises after cesarean delivery.
Behavioral: Paula exercises
The patients will perform Paula exercises after the cesarean delivery
Active Comparator: Gum chewing
The patients will chew gum after the cesarean delivery.
Behavioral: Gum chewing
The patients will be given chewing gum and will be asked to chew it after the cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first flatus or bowel movements
Time Frame: Up to one week from delivery
The patients will note the time of the first passing gas and the first bowel movement after the cesarean delivery.
Up to one week from delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 0491-22-HMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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