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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110600
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
amaal ehab mostafa, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Motility and Defecation Conditions Other: Coffee effect on early gastric motility Other: Efficacy pepper mint oil on motility Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of Coffee Versus Peppermint Oil Intake in Promoting GIT Motility After Cesarean Section
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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 Name: 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 Name: Pepper mint oil




Primary Outcome Measures :
  1. Regain of GIT motility after cesarean section by auscultation of intestinal sound [ Time Frame: First 12 hours after cs ]
    Auscultation of intestinal sounds hourly for first 12. Hours


Secondary Outcome Measures :
  1. Sense of nausea [ Time Frame: First 24 hours after cs ]
    Nausea sensation

  2. Sense of vomiting [ Time Frame: First 24 hours after cs ]
    Recording time for first time of vomiting

  3. First passage of flatus [ Time Frame: First 24 hours after cs ]
    Record first passage of flatus

  4. First defection [ Time Frame: First 24 hours after cs ]
    Record first bowel motjon

  5. Effect on abdominal distention [ Time Frame: First 24 hours after cs ]
    Recording incidence of distension

  6. Need of medication to enhance motility of GIT [ Time Frame: First 24 hours after cs ]
    Assessing need for extra medications for motility

  7. Length of hospital stay after surgery [ Time Frame: First 24 hours after cs ]
    Recording length of stay



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04110600


Locations
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Egypt
Ain shams maternity hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Study Director: Nermine Elghareb, Lecturer Ain Shams Maternity Hospital
Study Director: Ahmed Tharwat, Professor Ain Shams Maternity Hospital
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Responsible Party: amaal ehab mostafa, obstetrics and gynaecology resident, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT04110600    
Other Study ID Numbers: FWA000017585
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 amaal ehab mostafa, Ain Shams Maternity Hospital:
Bowel movements
Cesarean section
Oral hydration