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Trial record 10 of 77 for:    coffee

Effect of Coffee Consumption on Intestinal Motility

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ClinicalTrials.gov Identifier: NCT03191877
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mufareh Asiri, Armed Forces Hospitals, Southern Region, Saudi Arabia

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Motility Dietary Supplement: coffee Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of Coffee Consumption on Intestinal Motility After Caesarean Sections; Randomized Controlled Trial
Estimated Study Start Date : January 9, 2018
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: COFFEE
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.
Dietary Supplement: coffee
Nescafe "brand of coffee made by Nestlé", red mug 100 % pure coffee 12083811

Active Comparator: oral fluid

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.

Dietary Supplement: coffee
Nescafe "brand of coffee made by Nestlé", red mug 100 % pure coffee 12083811

No Intervention: control
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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Passage of flatus. . The amount of analgesia. The first Breastfeeding time. The initiation of Mobilization. Hospital length stay. [ Time Frame: 72 hours ]
    (time to be recorded by the 24-hour clock from finishing of surgery).

  2. Audible intestinal sound time. [ Time Frame: 72 hours ]
    Audible first intestinal sound time.(time to be recorded by the 24-hour clock from finishing of surgery).

  3. Feeding time [ Time Frame: 72 hours ]
    Feeding time (StARTING OF REGULAR DIET ).(time to be recorded by the 24-hour clock from finishing of surgery).

  4. Pain scale by VAS (Visual Analogue Scale ). [ Time Frame: 72 hours ]

    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).


  5. Type of analgesia needed. [ Time Frame: 72 hours ]
    Type of analgesia needed. (paracetamol, nonsteroidal anti-inflammatory drugs or pethidine ).

  6. The amount of analgesia . [ Time Frame: 72 hours ]
    ( recording of dose and frequency in time are mandatory ).

  7. The first Breastfeeding time. [ Time Frame: 72 hours ]
    (time to be recorded by 24-hour clock from finishing of surgery)

  8. The initiation of Mobilization. [ Time Frame: 72 hours ]
    (time to be recorded by 24-hour clock from finishing of surgery)

  9. Hospital length stay. [ Time Frame: 72 hours ]
    ( in Days )



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective caesarian section, singleton pregnancy, term, viable fetus

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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191877


Contacts
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Contact: Mufareh Asiri, SBOG 00966553725252 dr.mufareh@yahoo.com

Locations
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Saudi Arabia
AFHSR Recruiting
Khamis Mushait, Abha, Saudi Arabia, 16757
Contact: Mufareh Asiri, Saudi board    553725252    Dr.mufareh@yahoo.com   
Sponsors and Collaborators
Armed Forces Hospitals, Southern Region, Saudi Arabia
Investigators
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Study Chair: Mufareh Asiri, SBOG Postpartum ward of Armed Forces Hospital, Southern Region. Khamis Mushait, Asir, Saudi Arabia, 101

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Responsible Party: Mufareh Asiri, OB/GYN REGISTRAR, Armed Forces Hospitals, Southern Region, Saudi Arabia
ClinicalTrials.gov Identifier: NCT03191877     History of Changes
Other Study ID Numbers: H-06-KM-001
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mufareh Asiri, Armed Forces Hospitals, Southern Region, Saudi Arabia:
coffee consumption
Cesarean section
intestinal motility