Gastrointestinal MotilityNCT03191877
Effect of Coffee Consumption on Intestinal Motility
A study testing coffee in people with Gastrointestinal Motility, run by Armed Forces Hospitals, Southern Region, Saudi Arabia at 1 site in Saudi Arabia.
Trial summary
Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To measure the effect of coffee consumption on intestinal motility after caesarean section for the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary outcome and secondary outcome will be measured. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gastrointestinal Motility
- What is being tested?
- coffee
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 9 Jan 2018to 30 Jun 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- elective caesarian section, singleton pregnancy, term, viable fetus
Who cannot join
- medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance )
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
AFHSR
Khamis Mushait, Abha, 16757
Mufareh Asiri, Saudi board, 553725252, Dr.mufareh@yahoo.com
About this study
Official title: Effect of Coffee Consumption on Intestinal Motility After Caesarean Sections; Randomized Controlled Trial
Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To measure the effect of coffee consumption on intestinal motility after caesarean section for the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary outcome and secondary outcome will be measured.
Read the detailed description
Randomized controlled trial. Participants who fulfill the inclusion criteria (elective caesarian section, singleton pregnancy, term, viable fetus), and exclusion criteria (medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance ) Then they will be randomized to 3 groups. Group 1, will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound.
Group 2, will drink water 6 hours postoperative. Diet will start after 1st audible bowel sound.
Group 3 is the control group and they will be (NOTHING PER ORAL) for 24 hours on intravenous fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound.
Primary outcome: passage of stool. Secondary outcome: passage of flatus, audible intestinal sound time, feeding time, pain scale by Visual Analogue Scale (VAS), amount, and type of analgesia needed, breastfeeding time, mobilization and hospital stay.
- Conditions
- Gastrointestinal Motility
- Being tested
- coffee
- Keywords
- coffee consumption, Cesarean section, intestinal motility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffeeDietary supplement
Nescafe "brand of coffee made by Nestlé", red mug 100 % pure coffee 12083811
| Study group | Role | What they receive |
|---|---|---|
| COFFEE | Experimental | they will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound. Receives: Dietary Supplement: coffee |
| oral fluid | Active comparator | they will drink plain fluid (water) 6 hours postoperative. Diet will start after 1st audible bowel sound.
Women in this group will not receive either coffee. Receives: Dietary Supplement: coffee |
| control | No intervention | the control group and they will be NPO for 24 hours on IV fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
passage of stool.
passage of stool within 72 hours. (time to be recorded by 24-hour clock from finishing of surgery)
Measured: 72 hours
Secondary outcomes (9)
Passage of flatus. . The amount of analgesia. The first Breastfeeding time. The initiation of Mobilization. Hospital length stay.
(time to be recorded by the 24-hour clock from finishing of surgery).
Measured: 72 hours
Audible intestinal sound time.
Audible first intestinal sound time.(time to be recorded by the 24-hour clock from finishing of surgery).
Measured: 72 hours
Feeding time
Feeding time (StARTING OF REGULAR DIET ).(time to be recorded by the 24-hour clock from finishing of surgery).
Measured: 72 hours
Pain scale by VAS (Visual Analogue Scale ).
Pain scale by using Visual Analogue Scale(VAS). it is measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
No pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Measured: 72 hours
Type of analgesia needed.
Type of analgesia needed. (paracetamol, nonsteroidal anti-inflammatory drugs or pethidine ).
Measured: 72 hours
The amount of analgesia .
( recording of dose and frequency in time are mandatory ).
Measured: 72 hours
The first Breastfeeding time.
(time to be recorded by 24-hour clock from finishing of surgery)
Measured: 72 hours
The initiation of Mobilization.
(time to be recorded by 24-hour clock from finishing of surgery)
Measured: 72 hours
Hospital length stay.
( in Days )
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 posted19 Jun 2017
- Study start9 Jan 2018 (estimated)
- Primary completion30 May 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MotilityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mufareh Asiri, Armed Forces Hospitals, Southern Region, Saudi Arabia
- Investigators
- Mufareh Asiri, SBOG, Study chair, Postpartum ward of Armed Forces Hospital, Southern Region. Khamis Mushait, Asir, Saudi Arabia, 101
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191877
- Sponsor's protocol ID
- H-06-KM-001
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffee Consumption on Intestinal Motility After Caesarean Sections; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03191877
- Acronym / sponsor ID
- H-06-KM-001
- Conditions
- Gastrointestinal Motility
- Keywords
- coffee consumption, Cesarean section, intestinal motility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Armed Forces Hospitals, Southern Region, Saudi ArabiaOther government
- Study start
- 9 Jan 2018 (estimated)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 19 Jun 2017 (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.
Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To measure the effect of coffee consumption on intestinal motility after caesarean section for the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary outcome and secondary outcome will be measured.
Detailed description
Randomized controlled trial. Participants who fulfill the inclusion criteria (elective caesarian section, singleton pregnancy, term, viable fetus), and exclusion criteria (medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance ) Then they will be randomized to 3 groups. Group 1, will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound.
Group 2, will drink water 6 hours postoperative. Diet will start after 1st audible bowel sound.
Group 3 is the control group and they will be (NOTHING PER ORAL) for 24 hours on intravenous fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound.
Primary outcome: passage of stool. Secondary outcome: passage of flatus, audible intestinal sound time, feeding time, pain scale by Visual Analogue Scale (VAS), amount, and type of analgesia needed, breastfeeding time, mobilization and hospital stay.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COFFEE | Experimental | Dietary Supplement: coffeethey will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound. |
| oral fluid | Active comparator | Dietary Supplement: coffeethey will drink plain fluid (water) 6 hours postoperative. Diet will start after 1st audible bowel sound. Women in this group will not receive either coffee. |
| control | No intervention | –the control group and they will be NPO for 24 hours on IV fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- elective caesarian section, singleton pregnancy, term, viable fetus
Key exclusion criteria (1 listed)
- medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance )
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 |
|---|---|---|
| coffeeNescafe "brand of coffee made by Nestlé", red mug 100 % pure coffee 12083811 | Dietary supplement | COFFEE, oral fluid |
Primary outcome
passage of stool.
Time frame: 72 hours
passage of stool within 72 hours. (time to be recorded by 24-hour clock from finishing of surgery)
9 secondary outcomes
Passage of flatus. . The amount of analgesia. The first Breastfeeding time. The initiation of Mobilization. Hospital length stay.
Time frame: 72 hours
Audible intestinal sound time.
Time frame: 72 hours
Feeding time
Time frame: 72 hours
Pain scale by VAS (Visual Analogue Scale ).
Time frame: 72 hours
Type of analgesia needed.
Time frame: 72 hours
The amount of analgesia .
Time frame: 72 hours
The first Breastfeeding time.
Time frame: 72 hours
The initiation of Mobilization.
Time frame: 72 hours
Hospital length stay.
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mufareh Asiri, SBOG study chair
Postpartum ward of Armed Forces Hospital, Southern Region. Khamis Mushait, Asir, Saudi Arabia, 101
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 in people with Gastrointestinal Motility, run by Armed Forces Hospitals, Southern Region, Saudi Arabia at 1 site in Saudi Arabia.
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 1 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 9 Jan 2018. 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 Saudi Arabia. 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?
Contact Mufareh Asiri, SBOG (00966553725252, dr.mufareh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
passage of stool. (time frame: 72 hours). 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 9 Jan 2018.