Effect of Coffee Consumption on Intestinal Motility

Gastrointestinal Motility Clinical Trial

Official title:

Effect of Coffee Consumption on Intestinal Motility After Caesarean Sections; Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191877
• Other study ID #: H-06-KM-001
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2017
• Last updated: January 8, 2018
• Start date: January 9, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2017
• Source: Armed Forces Hospitals, Southern Region, Saudi Arabia
• Contact: Mufareh Asiri, SBOG
• Phone: 00966553725252
• Email: dr.mufareh[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Gastrointestinal Motility

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	AFHSR	Khamis Mushait	Abha

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Hospitals, Southern Region, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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