Effect of Coffee Consumption on Intestinal Motility

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Motility
• Intervention / Treatment: Dietary supplement: coffee

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mufareh Asiri, SBOG; Phone Number: 00966553725252; Email: dr.mufareh@yahoo.com

Study Locations

• Saudi Arabia
  • Abha
    • Khamis Mushait, Abha, Saudi Arabia, 16757
      • Recruiting
      • AFHSR
      • Contact: Mufareh Asiri, Saudi board; Phone Number: 553725252; Email: Dr.mufareh@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	72 hours
Audible intestinal sound time.	Audible first intestinal sound time.(time to be recorded by the 24-hour clock from finishing of surgery).	72 hours
Feeding time	Feeding time (StARTING OF REGULAR DIET ).(time to be recorded by the 24-hour clock from finishing of surgery).	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).	72 hours
Type of analgesia needed.	Type of analgesia needed. (paracetamol, nonsteroidal anti-inflammatory drugs or pethidine ).	72 hours
The amount of analgesia .	( recording of dose and frequency in time are mandatory ).	72 hours
The first Breastfeeding time.	(time to be recorded by 24-hour clock from finishing of surgery)	72 hours
The initiation of Mobilization.	(time to be recorded by 24-hour clock from finishing of surgery)	72 hours
Hospital length stay.	( in Days )	72 hours

Collaborators and Investigators

• Sponsor: Armed Forces Hospitals, Southern Region, Saudi Arabia
• Investigators: Study Chair: Mufareh Asiri, SBOG, Postpartum ward of Armed Forces Hospital, Southern Region. Khamis Mushait, Asir, Saudi Arabia, 101

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 9, 2018
• Primary Completion (ANTICIPATED): May 30, 2018
• Study Completion (ANTICIPATED): June 30, 2018

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (ACTUAL): June 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: coffee consumption; Cesarean section; intestinal motility
• Other Study ID Numbers: H-06-KM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No