Efficacy of Coffee Versus Peppermint Oil Intake in Promoting GIT Motility After Cesarean Section

It is a comparison between coffee effect versus peppermint oil in promoting GIT motility after cesarean section

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Motility and Defecation Conditions
• Intervention / Treatment: Other: Coffee effect on early gastric motility; Other: Efficacy pepper mint oil on motility

Detailed Description

This study includes 600 patients who underwent cesarean delivery under spinal anaethesia subdivided into two groups each contain 300 patients Group 1 will have 100 ml of coffee after 2,4 and 6 hours Group 2 will have 100 me of pepper mint oil After 2,4 and 6 hours

Then outcomes will be assessed as per time frame

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• willingness to participate.
• uncomplicated pregnancy.
• uncomplicated cesarean section.
• under regional anesthesia
• BMI<30kg/m.
• level of hemoglobin is 10g/dl or more

Exclusion Criteria:

• medical disorders in the form of HTN,DM and hepatic disorders and bleeding disorders
• intra operative bowel or bladder injury during the cesarean section
• intra operative severe bleeding
• chronic gastrointestinal problems like chronic constipation ,peptic ulcer ,esophagitis ,hiatus hernia and IBS
• sever intestinal adhesions
• Respiratory problems and infection that require medication intervention
• operation more than 90 minutes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coffee group; This group includes 300 patients who underwent cesarean delivery under spinal anaesthesia And will have 100 ml of coffee after 2,4 and 6 hours Then outcomes will be assessed as per time frame	Other: Coffee effect on early gastric motility; this group 100ml coffee after two hours; Other Names: Coffee intake
Active Comparator: Pepper mint oil group; This group includes 300 patients who underwent cesarean delivery under spinal anaesthesia This group will have 100 ml of pepper mint oil After 2,4 and 6 hours Then outcomes will be assessed as per time frame	Other: Efficacy pepper mint oil on motility; This group 100me pepper mint oil after 2 hours; Other Names: Pepper mint oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regain of GIT motility after cesarean section by auscultation of intestinal sound	Auscultation of intestinal sounds hourly for first 12. Hours	First 12 hours after cs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sense of nausea	Nausea sensation	First 24 hours after cs
Sense of vomiting	Recording time for first time of vomiting	First 24 hours after cs
First passage of flatus	Record first passage of flatus	First 24 hours after cs
First defection	Record first bowel motjon	First 24 hours after cs
Effect on abdominal distention	Recording incidence of distension	First 24 hours after cs
Need of medication to enhance motility of GIT	Assessing need for extra medications for motility	First 24 hours after cs
Length of hospital stay after surgery	Recording length of stay	First 24 hours after cs

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: Nermine Elghareb, Lecturer, Ain Shams Maternity Hospital; Study Director: Ahmed Tharwat, Professor, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: September 29, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 29, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Cesarean section; Oral hydration; Bowel movements
• Other Study ID Numbers: FWA000017585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No