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

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ClinicalTrials.gov Identifier: NCT03815877
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Madonna Gamal Garas Benyamine, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Ileus Cesarean Section Complications Caffeine Dietary Supplement: Nescafe Gold ® coffee Dietary Supplement: Nescafe Gold DECAF® coffee Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial
Masking: Single (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
Primary Purpose: Prevention
Official Title: The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section: A Randomized Controlled Trial
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : December 10, 2018
Actual Study Completion Date : January 12, 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: The intervention group (C group receiving caffeinated coffee)
100cc coffee at 3, 6 and 9 hours after the Cesarean section
 Dietary Supplement: Nescafe Gold ® coffee

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.
Placebo Comparator: The control group (N group receiving decaffeinated coffee)
100cc decaf coffee at 3, 6, 9 hours after the Cesarean section
 Dietary Supplement: Nescafe Gold DECAF® coffee

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.


Outcome Measures
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Primary Outcome Measures :
  1. A change in 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. ]
    A change the number of hours for women to pass flatus for the first time after an elective caesarean section


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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. ]
    A difference in the number of hours for the women to pass stool after caesarean section.

  3. 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 ]
    A difference in the number of the women's hospital stay hours after caesarean section

  4. 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. ]
    Occurrence of postoperative spinal headache


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815877


Locations
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Egypt
Ain Shams Maternity Hospital
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: AMR NADIM Ain Shams University
Study Director: REDA GHANEM Ain Shams University
Principal Investigator: MADONNA BENYAMINE Ain Shams University
  Study Documents (Full-Text)

Documents provided by Madonna Gamal Garas Benyamine, Ain Shams University:
Study Protocol and Statistical Analysis Plan  [PDF] January 18, 2018

More Information
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Publications:

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Responsible Party: Madonna Gamal Garas Benyamine, DR. MADONNA GAMAL GARAS BENYAMINE, Ain Shams University
ClinicalTrials.gov Identifier: NCT03815877    
Other Study ID Numbers: AinShamsU2018455
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madonna Gamal Garas Benyamine, Ain Shams University:
Caffeine
Postoperative Ileus
Caesarean Section
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases