Cesarean Delivery Affecting FetusNCT05729984
Paula Method Versus Chewing Gum for Postoperative Recovery After Caesarean Section
A study testing Paula exercises and Gum chewing in people with Cesarean Delivery Affecting Fetus and Post Operative Bowel Function, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery Affecting Fetus, Post Operative Bowel Function
- What is being tested?
- Paula exercises and Gum chewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Feb 2023to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women after an elective caesarean delivery
- Age 18+
- Ability to read and write in Hebrew
Who cannot join
- Diagnosis of chronic gastrointestinal diseases
- Inability to chew gum
- Use of laxatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Paula exercises, Gum chewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paula exercisesBehavioural
The patients will perform Paula exercises after the cesarean delivery
Gum chewingBehavioural
The patients will be given chewing gum and will be asked to chew it after the cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Paula | Experimental | The patients will perform Paula exercises after cesarean delivery. Receives: Behavioral: Paula exercises |
| Gum chewing | Active comparator | The patients will chew gum after the cesarean delivery. Receives: Behavioral: Gum chewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one week from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start20 Feb 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery Affecting FetusStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Rosenbloom, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729984
- Sponsor's protocol ID
- 0491-22-HMO
- Status last verified
- Sep 2023
- First submitted
- 31 Jan 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness of Paula Method Versus Chewing Gum for Postoperative Recovery of Gastrointestinal Function in Patients After Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT05729984
- Acronym / sponsor ID
- 0491-22-HMO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paula | Experimental | Behavioral: Paula exercisesThe patients will perform Paula exercises after cesarean delivery. |
| Gum chewing | Active comparator | Behavioral: Gum chewingThe patients will chew gum after the cesarean delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women after an elective caesarean delivery
- Age 18+
- Ability to read and write in Hebrew
Key exclusion criteria (3 listed)
- Diagnosis of chronic gastrointestinal diseases
- Inability to chew gum
- Use of laxatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paula exercisesThe patients will perform Paula exercises after the cesarean delivery | Behavioural | Paula |
| Gum chewingThe patients will be given chewing gum and will be asked to chew it after the cesarean delivery | Behavioural | Gum chewing |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paula exercises and Gum chewing in people with Cesarean Delivery Affecting Fetus and Post Operative Bowel Function, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first flatus or bowel movements (time frame: Up to one week from delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.