CClinicalTrials.gg
Status unknownNCT03191877Updated Jan 9, 2018

Effect of Coffee Consumption on Intestinal Motility

An interventional study of coffee in Gastrointestinal Motility, sponsored by Armed Forces Hospitals, Southern Region, Saudi Arabia. Status unknown at 1 site in Saudi Arabia. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by Armed Forces Hospitals, Southern Region, Saudi Arabia · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Gastrointestinal Motility

Keywords

  • coffee consumption
  • Cesarean section
  • intestinal motility
03

In context

Lead sponsor

Armed Forces Hospitals, Southern Region, Saudi Arabia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 )
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementcoffee

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

06

What researchers measure

Primary outcomes

  1. passage of stool.

    passage of stool within 72 hours. (time to be recorded by 24-hour clock from finishing of surgery)

    Time frame: 72 hours

Secondary outcomes

  1. 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).

    Time frame: 72 hours

  2. Audible intestinal sound time.

    Audible first intestinal sound time.(time to be recorded by the 24-hour clock from finishing of surgery).

    Time frame: 72 hours

  3. Feeding time

    Feeding time (StARTING OF REGULAR DIET ).(time to be recorded by the 24-hour clock from finishing of surgery).

    Time frame: 72 hours

  4. 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).

    Time frame: 72 hours

  5. Type of analgesia needed.

    Type of analgesia needed. (paracetamol, nonsteroidal anti-inflammatory drugs or pethidine ).

    Time frame: 72 hours

  6. The amount of analgesia .

    ( recording of dose and frequency in time are mandatory ).

    Time frame: 72 hours

  7. The first Breastfeeding time.

    (time to be recorded by 24-hour clock from finishing of surgery)

    Time frame: 72 hours

  8. The initiation of Mobilization.

    (time to be recorded by 24-hour clock from finishing of surgery)

    Time frame: 72 hours

  9. Hospital length stay.

    ( in Days )

    Time frame: 72 hours

07

Study locations

1 of 1 sites recruiting
  • AFHSR
    Khamis Mushait, Abha 16757, Saudi Arabia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03191877
Lead sponsor
Armed Forces Hospitals, Southern Region, Saudi Arabia
Responsible party
Mufareh Asiri (OB/GYN REGISTRAR, Armed Forces Hospitals, Southern Region, Saudi Arabia) — Principal investigator
First posted
Jun 19, 2017
Start date
Jan 9, 2018 (estimated)
Primary completion
May 30, 2018 (estimated)
Completion
Jun 30, 2018 (estimated)
Last update
Jan 9, 2018

Study contacts

Mufareh Asiri, SBOG
Contact
dr.mufareh@yahoo.com
00966553725252
Mufareh Asiri, SBOG
study chair · Postpartum ward of Armed Forces Hospital, Southern Region. Khamis Mushait, Asir, Saudi Arabia, 101

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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