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The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section.

Primary Purpose

Postoperative Ileus, Cesarean Section Complications, Caffeine

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nescafe Gold ® coffee
Nescafe Gold DECAF® coffee
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Ileus focused on measuring Caffeine, Postoperative Ileus, Caesarean Section

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • women undergoing caesarean section
  • Spinal anaesthesia
  • Total surgery time less than 90 minutes

Exclusion Criteria:

  • Previous complicated abdominal surgery or caesarean section with extensive adhesions requiring extensive dissection or intestinal manipulation.
  • Caesarean section complicated by postpartum hemorrhage or in the women who received misoprostol.
  • Intraoperative intestinal complications.
  • Intraoperative respiratory complication.
  • Chronic intestinal diseases: irritable or inflammatory bowel diseases.
  • Chronic diarrhea or constipation.
  • Using laxatives pre-operatively.
  • Known hypersensitivity to caffeine
  • Thyroid or hepatic disease.
  • Cardiac arrhythmias

Sites / Locations

  • Ain Shams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

The intervention group (C group receiving caffeinated coffee)

The control group (N group receiving decaffeinated coffee)

Arm Description

100cc coffee at 3, 6 and 9 hours after the Cesarean section

100cc decaf coffee at 3, 6, 9 hours after the Cesarean section

Outcomes

Primary Outcome Measures

A change in the number of hours for women to pass flatus for the first time after an elective caesarean section
A change the number of hours for women to pass flatus for the first time after an elective caesarean section

Secondary Outcome Measures

A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section
A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section.
A difference in the number of hours for the women to pass stool after caesarean section.
A difference in the number of hours for the women to pass stool after caesarean section.
A difference in the number of the women's hospital stay hours after caesarean section
A difference in the number of the women's hospital stay hours after caesarean section
Occurrence of postoperative spinal headache
Occurrence of postoperative spinal headache

Full Information

First Posted
January 17, 2018
Last Updated
January 23, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03815877
Brief Title
The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section.
Official Title
The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
January 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many trials have been made to prevent paralytic ileus , including administration of prokinetic drugs , early resumption of feeding, gum chewing and adequate pain control. Unfortunately, none of these strategies has been completely successful. Recently the effect of caffeine on prevention of postoperative ileus after caesarian section was researched. That's why this study is designed to determine the efficacy of caffeine in prevention of postoperative ileus after caesarean section.
Detailed Description
-Study design: This study will include 600 women undergoing their caesarean section. The study aims will be explained to all women and an informed written consent will be taken. All recruited women will be distributed into two groups according to a computerized randomization table. The researcher consecutively will open sequentially numbered, opaque, sealed envelopes containing cards with letters either letter (C) or letter (N), Cards with letter (C) will represent the group who will receive the caffeinated coffee and cards with letter (N) will represent the group who will receive the decaffeinated coffee Procedure: For all women, the anesthetic used will be Marcaine® Spinal heavy 0.5% and fentanyl and for post-operative pain, ketorolac will be used. Through Pfannenstiel incision, transverse lower segment uterine incision is done, with the duration of the surgery not exceeding 90 minutes women will not be permitted to drink or eat, except for the drink offered by the researcher, till passing flatus. Early ambulation will be encouraged. A stethoscope will be used to detect the first intestinal movement each hour after the surgery. The women will be advised to notify the researcher when they pass both flatus and feces. Intervention: The intervention plan will be performed within the first 24 hours after the surgery. Provided by the researcher within 10 minutes, patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery, and the control group will drink 100cc decaffeinated coffee with 1 tea spoon added sugar at the same intervals. No other liquid will be allowed till passage of flatus and feces in the first day of surgery. Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used for all the women in the intervention group. Nescafe Gold DECAF coffee (5 gm per 100cc water containing 5-10 mg of caffeine) will be used for all the women in the control group. Statistical Package: Data analysis will be performed by Statistical Package for the Social Science (SPSS) 16.0 using descriptive statistics tools, including mean, standard deviation and figures. A t-test will be used to compare mean values of the two groups. P-values, smaller than 0.05, were considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus, Cesarean Section Complications, Caffeine
Keywords
Caffeine, Postoperative Ileus, Caesarean Section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial
Masking
Participant
Masking Description
All recruited women will be distributed into two groups according to a computer- generated randomization table. The researcher consecutively will open sequentially numbered, opaque, sealed envelopes containing cards with letters either letter (C) or letter (N), Cards with letter (C) will represent the group who will receive the caffeinated coffee and cards with letter (N) will represent the group who will receive the decaffeinated coffee
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The intervention group (C group receiving caffeinated coffee)
Arm Type
Active Comparator
Arm Description
100cc coffee at 3, 6 and 9 hours after the Cesarean section
Arm Title
The control group (N group receiving decaffeinated coffee)
Arm Type
Placebo Comparator
Arm Description
100cc decaf coffee at 3, 6, 9 hours after the Cesarean section
Intervention Type
Dietary Supplement
Intervention Name(s)
Nescafe Gold ® coffee
Intervention Description
Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used for all the women in the intervention group. - patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nescafe Gold DECAF® coffee
Intervention Description
Nescafe Gold DECAF coffee (5 gm per 100cc water containing 5-10 mg of caffeine) will be used for all the women in the control group. the control group will drink 100cc decaffeinated coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery.
Primary Outcome Measure Information:
Title
A change in the number of hours for women to pass flatus for the first time after an elective caesarean section
Description
A change the number of hours for women to pass flatus for the first time after an elective caesarean section
Time Frame
patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass flatus.
Secondary Outcome Measure Information:
Title
A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section
Description
A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section.
Time Frame
patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. A stethoscope will be used to detect the first intestinal movement every hour after the surgery
Title
A difference in the number of hours for the women to pass stool after caesarean section.
Description
A difference in the number of hours for the women to pass stool after caesarean section.
Time Frame
patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass feces.
Title
A difference in the number of the women's hospital stay hours after caesarean section
Description
A difference in the number of the women's hospital stay hours after caesarean section
Time Frame
calculating the number of the women's hospital stay hours after caesarean section up to 12 weeks
Title
Occurrence of postoperative spinal headache
Description
Occurrence of postoperative spinal headache
Time Frame
patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher with the occurrence, severity and relief of spinal headache during the hospital stay.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women undergoing caesarean section Spinal anaesthesia Total surgery time less than 90 minutes Exclusion Criteria: Previous complicated abdominal surgery or caesarean section with extensive adhesions requiring extensive dissection or intestinal manipulation. Caesarean section complicated by postpartum hemorrhage or in the women who received misoprostol. Intraoperative intestinal complications. Intraoperative respiratory complication. Chronic intestinal diseases: irritable or inflammatory bowel diseases. Chronic diarrhea or constipation. Using laxatives pre-operatively. Known hypersensitivity to caffeine Thyroid or hepatic disease. Cardiac arrhythmias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMR NADIM
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
REDA GHANEM
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
MADONNA BENYAMINE
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section.

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