Cesarean Section ComplicationsNCT05283707
The Effect of Paula Method Exercises on Post-cesarean Section Distension
A study testing Paula Method Exercises in people with Cesarean Section Complications, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension. Method: The study was planned as a double-blind, randomized controlled experimental study. 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
- Cesarean Section Complications
- What is being tested?
- Paula Method Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 Dec 2022
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-45, who are planned to have an elective Cesarean Section (CD) under spinal anesthesia,
- Admitted to the service within six hours after cesarean section,
- No chronic Charles Bonnet Syndrome (CBS) disease,
- No history of serious (ilostomy, cholastomy, irritable bowel syndrome, etc.) disease related to the gastrointestinal tract,
- Those who volunteered to participate in the study and whose consent was obtained,
- No complications developed during or after the surgery,
- Women who do not have intellectual disability or perception problems and do not have communication difficulties will be included in the study.
- In order not to affect the research results; If there are women in the intervention and control group in the same hospital room, the last woman who was hospitalized in the same room will be excluded from the study.
Who cannot join
- Enema made,
- Any complication developed and taken to the intensive care unit,
- Not complying with the application process,
- The state of consciousness is not clear / will not be able to participate in the applications,
- Women who cannot communicate for any reason (hearing/speech/hearing, etc.) will be excluded from the research.
- Discharged before two days after cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of "Paula Method Exercises" on the Prevention of Postoperative Distention and Pain Due to Distention After Cesarean Section: A Randomized Controlled Study
Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension.
Method: The study was planned as a double-blind, randomized controlled experimental study.
Read more
The study was carried out between November 2021 and February 2022 with women who had undergone cesarean section at Akdeniz University Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study.
The number of individuals to be sampled from the population was determined by the G Power analysis and 80 women were included in the sample.
The data of the study were collected using the Introductory Information Form, the Postoperative Follow-up Form, and the McGill Pain Scale Form.
The women in the intervention group were given training on how to do the Paula Method Exercises in the postoperative period in line with the "Paula Method Exercises Training Plan" by the researcher.
Conclusion: It is predicted that the findings obtained from the data of the study will guide nursing care practices and new researches for the relief of gas and distension after cesarean section.
Read the detailed description
Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension. The gastrointestinal system problems experienced by all individuals undergoing abdominal surgery are important as they affect both the mother and the baby during the post-cesarean section period.
Method: The study was planned as a double-blind, randomized controlled experimental study. The study was carried out between November 2021 and February 2022 with women who had undergone cesarean section at Akdeniz University Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study. The number of individuals to be sampled from the population was determined by the G Power analysis and 80 women were included in the sample. Equal numbers of 80 women who agreed to participate in the study were assigned to the intervention and control groups (https://www.random.org) using the simple randomization method using a simple random numbers table. Women in the intervention and control groups received standard postoperative care in the clinic after cesarean section. In addition, the women in the intervention group were given training on how to do the Paula Method Exercises in the postoperative period in line with the "Paula Method Exercises Training Plan" by the researcher, and the "Paula Method Exercises Card" and "Paula Method Exercises Practice Video" were used, which facilitated the practice of the exercises. Paula Method Exercises were applied to the women in the intervention group by the researcher for 10-15 minutes on postoperative day 0, day 1 and day 2. The data of the study were collected with the "Descriptive Information Form", "Postoperative Follow-up Form" and "McGill Pain Scale Short Form". To both research groups; "Postoperative Follow-up Form" and "McGill Pain Scale Short Form" were applied between 6th and 8th hours, 1st and 2nd days after cesarean section. After the data are collected, the women in the control group will be given Paula Method Exercises training before discharge.
Conclusion: It is predicted that the findings obtained from the data of the study will guide nursing care practices and new researches for the relief of gas and distension after cesarean section.
- Conditions
- Cesarean Section Complications
- Being tested
- Paula Method Exercises
- Keywords
- Distantion, Paula Method Exercises,, Flatulence, Abdominal Pain, Post Cesarean Care, Gas
- Medical subject headings
- Flatulence, Abdominal Pain, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paula Method ExercisesBehavioural
The Paula Method Exercises were administered by the researcher for 6 to 8 hours, for 10 to 15 minutes on the post-op first day and post-op second day, to women who had a cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | * Continuation of standard post-cesarean section care in the clinic.
* Implementation of Paula Method Exercises Training Plan 6-8 hours after cesarean section (Paula Method Exercises Practice Card PEUK, Paula Method Exercises Video, Paula Method Exercises Flipcard)
* Paula Method Exercises; by the researcher, after cesarean section 0.day 6-8 hours, 1st day morning, 2nd day morning.
* Paula Method Exercises; It was applied by the researcher to the patient on the 0th day 6-8 hours, the 1st day in the morning, and the 2nd day in the morning after the cesarean section.
* 6-8 hours on day 0, morning on day 1, morning on day 2 after cesarean section Evaluation and recording of bowel sounds before and after Paula Method Exercises, application of "McGill Pain Scale Short Form",
* Evaluation of first flatulence after cesarean section and first defecation Receives: Behavioral: Paula Method Exercises |
| Control Group | No intervention | * Continuation of standard post-cesarean section care in the clinic. * 6-8 hours on day 0, morning on day 1, morning on day 2 after cesarean section Evaluation and recording of bowel sounds, application of "McGill Pain Scale Short Form", * Evaluation of first flatulence after cesarean section and first degassing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bowel movements
An increase in womens' number of bowel movements is a measure of outcome. This increase will be counted by listening with a stethoscope. For the first measurement, bowel sounds will be heard 2 times between 6-8 hours after cesarean section, before and after the intervention. For the second measurement, bowel sounds will be listened to 2 times in the morning on the post-op 1st day after cesarean section, before and after the intervention. For the third measurement, bowel sounds will be listened to 2 times in the morning on the post-op 2nd day after cesarean section, before and after the intervention. Bowel sounds will be listened to 6 times in total. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will decrease the time to pass gas and defecation (in hours) and increase the bowel sounds (in numbers). Significance level is set at p<0.05 in analyzes.
Measured: Bowel sounds will be listened to 6 times. The first measurement will be done between 6-8 hours after cesarean section, the second measurement will be done in the morning on the post-op 1st day, and the third in the morning on the 2nd post-op day.
Visual Analogue Scale
Application of Paula Method Exercises in the postoperative period after cesarean section; It is predicted that the Visual Analogue Scale score will decrease in the evaluation of pain due to distention. The minimum value is 0, the maximum value is 10. A low score indicates the success of the attempt. Significance level is set at p<0.05 in analyzes.
Measured: Pain will be evaluated 6 times. The first measurement will be made between 6-8 hours after cesarean section, the second measurement will be made in the morning on the 1st postoperative day, and the third in the morning on the 2nd day after the operation.
First gas extraction time
Until the patient has his first gas; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p<0.05.
Measured: Until you take your first gas; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.
First defecation extraction time
Until the patient has his first defecation; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p<0.05.
Measured: Until you take your first defecation; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Nov 2021
- Primary completion28 Jan 2022
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabiye DEMIR ISIK, Akdeniz University
- Investigators
- Rabiye Demir Işık, Principal investigator, Akdeniz Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283707
- Sponsor's protocol ID
- Akd-3739
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liebergall-Wischnitzer M, Hochner-Celnikier D, Lavy Y, Manor O, Shveiky D, Paltiel O. Randomized trial of circular muscle versus pelvic floor training for stress urinary incontinence in women. J Womens Health (Larchmt). 2009 Mar;18(3):377-85. doi: 10.1089/jwh.2008.0950.
PubMed 19281321Liebergall-Wischnitzer M, Paltiel O, Hochner Celnikier D, Lavy Y, Manor O, Woloski Wruble AC. Sexual function and quality of life of women with stress urinary incontinence: a randomized controlled trial comparing the Paula method (circular muscle exercises) to pelvic floor muscle training (PFMT) exercises. J Sex Med. 2012 Jun;9(6):1613-23. doi: 10.1111/j.1743-6109.2012.02721.x. Epub 2012 Apr 17.
PubMed 22510279Liebergall-Wischnitzer M, Shvieky D, Lavy Y, Woloski Wruble A, Noble A, Vaknin A. Paula Method (Circular Muscle Exercise) for Urinary Incontinence Symptoms of Women with Multiple Sclerosis: A Pilot Study. J Altern Complement Med. 2020 Jul;26(7):652-653. doi: 10.1089/acm.2020.0069. Epub 2020 May 29. No abstract available.
PubMed 32471333Liebergall-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 33249611Liebergall-Wischnitzer M, Hochner-Celnikier D, Lavy Y, Manor O, Arbel R, Paltiel O. Paula method of circular muscle exercises for urinary stress incontinence--a clinical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Sep-Oct;16(5):345-51. doi: 10.1007/s00192-004-1261-6. Epub 2005 Jan 20.
PubMed 15660184
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "Paula Method Exercises" on the Prevention of Postoperative Distention and Pain Due to Distention After Cesarean Section: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05283707
- Acronym / sponsor ID
- Akd-3739
- Conditions
- Cesarean Section Complications
- Keywords
- Distantion, Paula Method Exercises,, Flatulence, Abdominal Pain, Post Cesarean Care, Gas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 17 Mar 2022 (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.
Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension.
Method: The study was planned as a double-blind, randomized controlled experimental study.
The study was carried out between November 2021 and February 2022 with women who had undergone cesarean section at Akdeniz University Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study.
The number of individuals to be sampled from the population was determined by the G Power analysis and 80 women were included in the sample.
The data of the study were collected using the Introductory Information Form, the Postoperative Follow-up Form, and the McGill Pain Scale Form.
The women in the intervention group were given training on how to do the Paula Method Exercises in the postoperative period in line with the "Paula Method Exercises Training Plan" by the researcher.
Conclusion: It is predicted that the findings obtained from the data of the study will guide nursing care practices and new researches for the relief of gas and distension after cesarean section.
Detailed description
Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension. The gastrointestinal system problems experienced by all individuals undergoing abdominal surgery are important as they affect both the mother and the baby during the post-cesarean section period.
Method: The study was planned as a double-blind, randomized controlled experimental study. The study was carried out between November 2021 and February 2022 with women who had undergone cesarean section at Akdeniz University Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study. The number of individuals to be sampled from the population was determined by the G Power analysis and 80 women were included in the sample. Equal numbers of 80 women who agreed to participate in the study were assigned to the intervention and control groups (https://www.random.org) using the simple randomization method using a simple random numbers table. Women in the intervention and control groups received standard postoperative care in the clinic after cesarean section. In addition, the women in the intervention group were given training on how to do the Paula Method Exercises in the postoperative period in line with the "Paula Method Exercises Training Plan" by the researcher, and the "Paula Method Exercises Card" and "Paula Method Exercises Practice Video" were used, which facilitated the practice of the exercises. Paula Method Exercises were applied to the women in the intervention group by the researcher for 10-15 minutes on postoperative day 0, day 1 and day 2. The data of the study were collected with the "Descriptive Information Form", "Postoperative Follow-up Form" and "McGill Pain Scale Short Form". To both research groups; "Postoperative Follow-up Form" and "McGill Pain Scale Short Form" were applied between 6th and 8th hours, 1st and 2nd days after cesarean section. After the data are collected, the women in the control group will be given Paula Method Exercises training before discharge.
Conclusion: It is predicted that the findings obtained from the data of the study will guide nursing care practices and new researches for the relief of gas and distension after cesarean section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Paula Method Exercises* Continuation of standard post-cesarean section care in the clinic. * Implementation of Paula Method Exercises Training Plan 6-8 hours after cesarean section (Paula Method Exercises Practice Card PEUK, Paula Method Exercises Video, Paula Method Exercises Flipcard) * Paula Method Exercises; by the researcher, after cesarean section 0.day 6-8 hours, 1st day morning, 2nd day morning. * Paula Method Exercises; It was applied by the researcher to the patient on the 0th day 6-8 hours, the 1st day in the morning, and the 2nd day in the morning after the cesarean section. * 6-8 hours on day 0, morning on day 1, morning on day 2 after cesarean section Evaluation and recording of bowel sounds before and after Paula Method Exercises, application of "McGill Pain Scale Short Form", * Evaluation of first flatulence after cesarean section and first defecation |
| Control Group | No intervention | –* Continuation of standard post-cesarean section care in the clinic. * 6-8 hours on day 0, morning on day 1, morning on day 2 after cesarean section Evaluation and recording of bowel sounds, application of "McGill Pain Scale Short Form", * Evaluation of first flatulence after cesarean section and first degassing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between the ages of 18-45, who are planned to have an elective Cesarean Section (CD) under spinal anesthesia,
- Admitted to the service within six hours after cesarean section,
- No chronic Charles Bonnet Syndrome (CBS) disease,
- No history of serious (ilostomy, cholastomy, irritable bowel syndrome, etc.) disease related to the gastrointestinal tract,
- Those who volunteered to participate in the study and whose consent was obtained,
Key exclusion criteria (6 listed)
- Enema made,
- Any complication developed and taken to the intensive care unit,
- Not complying with the application process,
- The state of consciousness is not clear / will not be able to participate in the applications,
- Women who cannot communicate for any reason (hearing/speech/hearing, etc.) will be excluded from the research.
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 Method ExercisesThe Paula Method Exercises were administered by the researcher for 6 to 8 hours, for 10 to 15 minutes on the post-op first day and post-op second day, to women who had a cesarean section. | Behavioural | Intervention Group |
Primary outcome
Number of bowel movements
Time frame: Bowel sounds will be listened to 6 times. The first measurement will be done between 6-8 hours after cesarean section, the second measurement will be done in the morning on the post-op 1st day, and the third in the morning on the 2nd post-op day.
An increase in womens' number of bowel movements is a measure of outcome. This increase will be counted by listening with a stethoscope. For the first measurement, bowel sounds will be heard 2 times between 6-8 hours after cesarean section, before and after the intervention. For the second measurement, bowel sounds will be listened to 2 times in the morning on the post-op 1st day after cesarean section, before and after the intervention. For the third measurement, bowel sounds will be listened to 2 times in the morning on the post-op 2nd day after cesarean section, before and after the intervention. Bowel sounds will be listened to 6 times in total. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will decrease the time to pass gas and defecation (in hours) and increase the bowel sounds (in numbers). Significance level is set at p<0.05 in analyzes.
Visual Analogue Scale
Time frame: Pain will be evaluated 6 times. The first measurement will be made between 6-8 hours after cesarean section, the second measurement will be made in the morning on the 1st postoperative day, and the third in the morning on the 2nd day after the operation.
Application of Paula Method Exercises in the postoperative period after cesarean section; It is predicted that the Visual Analogue Scale score will decrease in the evaluation of pain due to distention. The minimum value is 0, the maximum value is 10. A low score indicates the success of the attempt. Significance level is set at p<0.05 in analyzes.
First gas extraction time
Time frame: Until you take your first gas; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.
Until the patient has his first gas; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p<0.05.
First defecation extraction time
Time frame: Until you take your first defecation; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.
Until the patient has his first defecation; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p<0.05.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 19281321Liebergall-Wischnitzer M, Hochner-Celnikier D, Lavy Y, Manor O, Shveiky D, Paltiel O. Randomized trial of circular muscle versus pelvic floor training for stress urinary incontinence in women. J Womens Health (Larchmt). 2009 Mar;18(3):377-85. doi: 10.1089/jwh.2008.0950.
- Background: PubMed 22510279Liebergall-Wischnitzer M, Paltiel O, Hochner Celnikier D, Lavy Y, Manor O, Woloski Wruble AC. Sexual function and quality of life of women with stress urinary incontinence: a randomized controlled trial comparing the Paula method (circular muscle exercises) to pelvic floor muscle training (PFMT) exercises. J Sex Med. 2012 Jun;9(6):1613-23. doi: 10.1111/j.1743-6109.2012.02721.x. Epub 2012 Apr 17.
- Background: PubMed 32471333Liebergall-Wischnitzer M, Shvieky D, Lavy Y, Woloski Wruble A, Noble A, Vaknin A. Paula Method (Circular Muscle Exercise) for Urinary Incontinence Symptoms of Women with Multiple Sclerosis: A Pilot Study. J Altern Complement Med. 2020 Jul;26(7):652-653. doi: 10.1089/acm.2020.0069. Epub 2020 May 29. No abstract available.
- Background: 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.
- Background: PubMed 15660184Liebergall-Wischnitzer M, Hochner-Celnikier D, Lavy Y, Manor O, Arbel R, Paltiel O. Paula method of circular muscle exercises for urinary stress incontinence--a clinical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Sep-Oct;16(5):345-51. doi: 10.1007/s00192-004-1261-6. Epub 2005 Jan 20.
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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.
Rabiye Demir Işık principal investigator
Akdeniz Univercity
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 Method Exercises in people with Cesarean Section Complications, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Number of bowel movements (time frame: Bowel sounds will be listened to 6 times. The first measurement will be done between 6-8 hours after cesarean section, the second measurement will be done in the morning on the post-op 1st day, and the third in the morning on the 2nd post-op day.). The study lists 4 primary outcomes in all. 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 NCT05283707, which also lists 5 linked publications.
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 17 Mar 2022.