Gastrointestinal Motility and Defecation ConditionsNCT04110600
Efficacy of Coffee Versus Peppermint Oil Intake in Promoting GIT Motility After Cesarean Section
A study testing Coffee effect on early gastric motility and Efficacy pepper mint oil on motility in people with Gastrointestinal Motility and Defecation Conditions, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
It is a comparison between coffee effect versus peppermint oil in promoting GIT motility after cesarean section Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility and Defecation Conditions
- What is being tested?
- Coffee effect on early gastric motility and Efficacy pepper mint oil on motility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 20 Sep 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- willingness to participate.
- uncomplicated pregnancy.
- uncomplicated cesarean section.
- under regional anesthesia
- BMI<30kg/m.
- level of hemoglobin is 10g/dl or more
Who cannot join
- medical disorders in the form of HTN,DM and hepatic disorders and bleeding disorders
- intra operative bowel or bladder injury during the cesarean section
- intra operative severe bleeding
- chronic gastrointestinal problems like chronic constipation ,peptic ulcer ,esophagitis ,hiatus hernia and IBS
- sever intestinal adhesions
- Respiratory problems and infection that require medication intervention
- operation more than 90 minutes
Trial locations and contacts
1 site in 1 country.
About this study
It is a comparison between coffee effect versus peppermint oil in promoting GIT motility after cesarean section
Read the detailed description
This study includes 600 patients who underwent cesarean delivery under spinal anaethesia subdivided into two groups each contain 300 patients Group 1 will have 100 ml of coffee after 2,4 and 6 hours Group 2 will have 100 me of pepper mint oil After 2,4 and 6 hours
Then outcomes will be assessed as per time frame
- Being tested
- Coffee effect on early gastric motility, Efficacy pepper mint oil on motility
- Keywords
- Bowel movements, Cesarean section, Oral hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee effect on early gastric motilityOther
Also called Coffee intake
this group 100ml coffee after two hours
Efficacy pepper mint oil on motilityOther
Also called Pepper mint oil
This group 100me pepper mint oil after 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Coffee group | Active comparator | This group includes 300 patients who underwent cesarean delivery under spinal anaesthesia And will have 100 ml of coffee after 2,4 and 6 hours
Then outcomes will be assessed as per time frame Receives: Other: Coffee effect on early gastric motility |
| Pepper mint oil group | Active comparator | This group includes 300 patients who underwent cesarean delivery under spinal anaesthesia This group will have 100 ml of pepper mint oil After 2,4 and 6 hours
Then outcomes will be assessed as per time frame Receives: Other: Efficacy pepper mint oil on motility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regain of GIT motility after cesarean section by auscultation of intestinal sound
Auscultation of intestinal sounds hourly for first 12. Hours
Measured: First 12 hours after cs
Secondary outcomes (7)
Sense of nausea
Nausea sensation
Measured: First 24 hours after cs
Sense of vomiting
Recording time for first time of vomiting
Measured: First 24 hours after cs
First passage of flatus
Record first passage of flatus
Measured: First 24 hours after cs
First defection
Record first bowel motjon
Measured: First 24 hours after cs
Effect on abdominal distention
Recording incidence of distension
Measured: First 24 hours after cs
Need of medication to enhance motility of GIT
Assessing need for extra medications for motility
Measured: First 24 hours after cs
Length of hospital stay after surgery
Recording length of stay
Measured: First 24 hours after cs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Mar 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Motility and Defecation ConditionsStudies 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
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amaal ehab mostafa, Ain Shams Maternity Hospital
- Investigators
- Nermine Elghareb, Lecturer, Study director, Ain Shams Maternity HospitalAhmed Tharwat, Professor, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110600
- Sponsor's protocol ID
- FWA000017585
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Coffee Versus Peppermint Oil Intake in Promoting GIT Motility After Cesarean Section
- ClinicalTrials.gov ID
- NCT04110600
- Acronym / sponsor ID
- FWA000017585
- Keywords
- Bowel movements, Cesarean section, Oral hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 1 Oct 2019 (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.
It is a comparison between coffee effect versus peppermint oil in promoting GIT motility after cesarean section
Detailed description
This study includes 600 patients who underwent cesarean delivery under spinal anaethesia subdivided into two groups each contain 300 patients Group 1 will have 100 ml of coffee after 2,4 and 6 hours Group 2 will have 100 me of pepper mint oil After 2,4 and 6 hours
Then outcomes will be assessed as per time frame
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee group | Active comparator | Other: Coffee effect on early gastric motilityThis group includes 300 patients who underwent cesarean delivery under spinal anaesthesia And will have 100 ml of coffee after 2,4 and 6 hours Then outcomes will be assessed as per time frame |
| Pepper mint oil group | Active comparator | Other: Efficacy pepper mint oil on motilityThis group includes 300 patients who underwent cesarean delivery under spinal anaesthesia This group will have 100 ml of pepper mint oil After 2,4 and 6 hours Then outcomes will be assessed as per time frame |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- willingness to participate.
- uncomplicated pregnancy.
- uncomplicated cesarean section.
- under regional anesthesia
- BMI<30kg/m.
Key exclusion criteria (7 listed)
- medical disorders in the form of HTN,DM and hepatic disorders and bleeding disorders
- intra operative bowel or bladder injury during the cesarean section
- intra operative severe bleeding
- chronic gastrointestinal problems like chronic constipation ,peptic ulcer ,esophagitis ,hiatus hernia and IBS
- sever intestinal adhesions
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 |
|---|---|---|
| Coffee effect on early gastric motilityAlso: Coffee intakethis group 100ml coffee after two hours | Other | Coffee group |
| Efficacy pepper mint oil on motilityAlso: Pepper mint oilThis group 100me pepper mint oil after 2 hours | Other | Pepper mint oil group |
Primary outcome
Regain of GIT motility after cesarean section by auscultation of intestinal sound
Time frame: First 12 hours after cs
Auscultation of intestinal sounds hourly for first 12. Hours
7 secondary outcomes
Sense of nausea
Time frame: First 24 hours after cs
Sense of vomiting
Time frame: First 24 hours after cs
First passage of flatus
Time frame: First 24 hours after cs
First defection
Time frame: First 24 hours after cs
Effect on abdominal distention
Time frame: First 24 hours after cs
Need of medication to enhance motility of GIT
Time frame: First 24 hours after cs
Length of hospital stay after surgery
Time frame: First 24 hours after cs
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 1 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Motility and Defecation Conditions
Recruiting
"The Effect of Abdominal Massage on Gastrointestinal Functions in Mechanically Ventilated Patients Receiving Enteral Nutrition in Intensive Care"
Defecation Disorder, Gastrointestinal Motility Disorder
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.
Nermine Elghareb, Lecturer study director
Ain Shams Maternity Hospital
Ahmed Tharwat, Professor study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee effect on early gastric motility and Efficacy pepper mint oil on motility in people with Gastrointestinal Motility and Defecation Conditions, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 6 inclusion and 7 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 1 Oct 2019. 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 Egypt. 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?
Regain of GIT motility after cesarean section by auscultation of intestinal sound (time frame: First 12 hours after cs). 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 1 Oct 2019.