Bowel DysfunctionNCT03761147
Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care
A study testing Paula exercises in people with Bowel Dysfunction, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bowel Dysfunction
- What is being tested?
- Paula exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective, singleton, term CS, with spinal or epidural anesthesia
Who cannot join
- GI/ absorption disorders (Chron's, IBS)
- general anesthesia
- urgent CS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Women's First Gastrointestinal Activation Post-elective Cesarean Birth During Post-partum Hospitalization:A Comparison of Paula Method (the Circular Exercises Method) to Standard Care
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).
- Conditions
- Bowel Dysfunction
- Being tested
- Paula exercises
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paula exercisesOther
structured exercises aimed to stimulate ring muscles
| Study group | Role | What they receive |
|---|---|---|
| Paula Method | Experimental | Not described Receives: Other: Paula exercises |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage
flatus passage
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Feb 2018
- Primary completion31 Jul 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel DysfunctionStudies of the same condition, open and under way.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761147
- Sponsor's protocol ID
- GI PAULA-HMO-CTIL
- Status last verified
- May 2020
- First submitted
- 26 Nov 2017
- Last updated
- 20 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33249611
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's First Gastrointestinal Activation Post-elective Cesarean Birth During Post-partum Hospitalization:A Comparison of Paula Method (the Circular Exercises Method) to Standard Care
- ClinicalTrials.gov ID
- NCT03761147
- Acronym / sponsor ID
- GI PAULA-HMO-CTIL
- Conditions
- Bowel Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paula Method | Experimental | Other: Paula exercises |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elective, singleton, term CS, with spinal or epidural anesthesia
Key exclusion criteria (3 listed)
- GI/ absorption disorders (Chron's, IBS)
- general anesthesia
- urgent CS
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 exercisesstructured exercises aimed to stimulate ring muscles | Other | Paula Method |
Primary outcome
Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage
Time frame: 72 hours
flatus passage
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33249611Liebergall-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.
- 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 in people with Bowel Dysfunction, 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 1 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 20 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 the Resumption of Bowel Functioning as Assessed by Flatus Passage (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761147, which also lists 1 linked publication.
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 20 Sep 2021.