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

NCT04110600 | Completed DMC

• 1 other identifier: FWA000017585
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastrointestinal Motility and Defecation Conditions

Keywords

Bowel movements; Cesarean section; Oral hydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Sense of nausea

  First 24 hours after cs

• Sense of vomiting

  First 24 hours after cs

• First passage of flatus

  First 24 hours after cs

• First defection

  First 24 hours after cs

• Effect on abdominal distention

  First 24 hours after cs

Study Arms (2)

Coffee group

ACTIVE COMPARATOR

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

Pepper mint oil group

ACTIVE COMPARATOR

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

Interventions

Coffee effect on early gastric motility OTHER

this group 100ml coffee after two hours

Also known as: Coffee intake

Coffee group

Efficacy pepper mint oil on motility OTHER

This group 100me pepper mint oil after 2 hours

Also known as: Pepper mint oil

Pepper mint oil group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain shams maternity hospital

Cairo, Egypt

Location

Study Officials

• Nermine Elghareb, Lecturer

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

• Ahmed Tharwat, Professor

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: obstetrics and gynaecology resident

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: October 1, 2019
• Study Start: March 1, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)