Effect of Coffee Consumption on Intestinal Motility

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastrointestinal Motility

Intervention / Treatment
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* Dietary Supplement: coffee


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COFFEE<br>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<br>* Nescafe brand of coffee made by Nestlé, red mug 100 % pure coffee 12083811<br>|
| Active Comparator: oral fluid<br>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<br>* Nescafe brand of coffee made by Nestlé, red mug 100 % pure coffee 12083811<br>|
| No Intervention: control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coffee consumption, Cesarean section, intestinal motility