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

January 23, 2019 updated by: Madonna Gamal Garas Benyamine, Ain Shams University

The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Ain Shams Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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 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
calculating the number of the women's hospital stay hours after caesarean section up to 12 weeks
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: AMR NADIM, Ain shams university
  • Study Director: REDA GHANEM, Ain shams university
  • Principal Investigator: MADONNA BENYAMINE, Ain shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 17, 2018

Primary Completion (ACTUAL)

December 10, 2018

Study Completion (ACTUAL)

January 12, 2019

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 23, 2019

First Posted (ACTUAL)

January 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinShamsU2018455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cesarean Section Complications

Clinical Trials on Nescafe Gold ® coffee

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe