Clinical trial NCT03191877: Effect of Coffee Consumption on Intestinal Motility
Official title: Effect of Coffee Consumption on Intestinal Motility After Caesarean Sections; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Motility
Keywords: coffee consumption
Cesarean section
intestinal motility
Lead sponsor: Armed Forces Hospitals, Southern Region, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2017-06-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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 )

Primary outcomes:
measure: passage of stool.
timeFrame: 72 hours
Secondary outcomes:
measure: Passage of flatus. . The amount of analgesia. The first Breastfeeding time. The initiation of Mobilization. Hospital length stay.
timeFrame: 72 hours
measure: Audible intestinal sound time.
timeFrame: 72 hours
measure: Feeding time
timeFrame: 72 hours
measure: Pain scale by VAS (Visual Analogue Scale ).
timeFrame: 72 hours
measure: Type of analgesia needed.
timeFrame: 72 hours
measure: The amount of analgesia .
timeFrame: 72 hours
measure: The first Breastfeeding time.
timeFrame: 72 hours
measure: The initiation of Mobilization.
timeFrame: 72 hours
measure: Hospital length stay.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: AFHSR
state: Abha
Study officials:
affiliation: Postpartum ward of Armed Forces Hospital, Southern Region. Khamis Mushait, Asir, Saudi Arabia, 101
name: Mufareh Asiri, SBOG
role: STUDY_CHAIR
References: