NCT05729984

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

January 31, 2023

Last Update Submit

September 21, 2023

Conditions

Cesarean Delivery Affecting FetusPost Operative Bowel Function

Outcome Measures

Primary Outcomes (1)

  • Time to first flatus or bowel movements

    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

Study Arms (2)

Paula

EXPERIMENTAL

The patients will perform Paula exercises after cesarean delivery.

Behavioral: Paula exercises

Gum chewing

ACTIVE COMPARATOR

The patients will chew gum after the cesarean delivery.

Behavioral: Gum chewing

Interventions

Paula exercisesBEHAVIORAL

The patients will perform Paula exercises after the cesarean delivery

Paula
Gum chewingBEHAVIORAL

The patients will be given chewing gum and will be asked to chew it after the cesarean delivery

Gum chewing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 15, 2023

Study Start

February 20, 2023

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)