Back to resultsMouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery
Primary Purpose
Prevention of Postoperative Ileus
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Mosapride
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Postoperative Ileus focused on measuring Postoperative ileus, mosapride, mouth dissolving tablets, Intraoperative vomiting
Eligibility Criteria
Inclusion Criteria:
- all women undergoing elective cesarean section
Exclusion Criteria:
- prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
Sites / Locations
- Ashraf nassif Elmantwe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mouth dissolving mosapride
Placebo mouth dissolving tablets
Arm Description
Fluxopride 5mg of Macryrl egypt 2 tablets one day before and immediately after elective cesarean section every 8hour for maximum of 5 days
Dummy identical tablets taken in the same way
Outcomes
Primary Outcome Measures
Time of first flatus
Clinical
Secondary Outcome Measures
Paralytic ileus incidence and its severity
Clinical
Toleration of fluids and solids intake
Clinical
Incidence of intraoperative and postoperative nausea and vomiting
Clinical
First defecation
Clinical
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03477266
Brief Title
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery
Official Title
Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Giving women one day before and immediately after cesarean section a mouthly dissolving mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered gastrointestinal functions And assess preoperative gastrointestinal functions
Detailed Description
Uncomplicated post cesarean women one day before and immediately after elective cesarean receive 2 mouthly dissolving mosapride tablets every 8 hours maximum for 5 days and clinical care giver follow the woman's gastrointestinal functions, including intraoperative and postoperative nausea vomiting, passing flatus, hearing intestinal sounds, passing stools, occurring of paralytic ileus, length of the hospital stay
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Postoperative Ileus
Keywords
Postoperative ileus, mosapride, mouth dissolving tablets, Intraoperative vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Color coded active tablets backed in red while identical dummy tablets coded in blue,both tablets are physically identical and usually no anticipated noticed side effects from mosapride
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mouth dissolving mosapride
Arm Type
Experimental
Arm Description
Fluxopride 5mg of Macryrl egypt 2 tablets one day before and immediately after elective cesarean section every 8hour for maximum of 5 days
Arm Title
Placebo mouth dissolving tablets
Arm Type
Placebo Comparator
Arm Description
Dummy identical tablets taken in the same way
Intervention Type
Drug
Intervention Name(s)
Mosapride
Other Intervention Name(s)
Fluxopride
Intervention Description
Intake mouthly dissolving mosapride tablets in immediate post cesarean section
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Dummy identical tablets to mouthly dissolving mosapride tablets
Primary Outcome Measure Information:
Title
Time of first flatus
Description
Clinical
Time Frame
96 hours postoperative
Secondary Outcome Measure Information:
Title
Paralytic ileus incidence and its severity
Description
Clinical
Time Frame
7days
Title
Toleration of fluids and solids intake
Description
Clinical
Time Frame
2 weeks postoperative
Title
Incidence of intraoperative and postoperative nausea and vomiting
Description
Clinical
Time Frame
Intraoperative and 2 weeks postoperative
Title
First defecation
Description
Clinical
Time Frame
2 weeks postoperative
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
After cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all women undergoing elective cesarean section
Exclusion Criteria:
prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf N Elmantwe, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashraf nassif Elmantwe
City
Banha
State/Province
Elqalopia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Once data collected and analyzed and published
IPD Sharing Time Frame
When data became available and for ever
IPD Sharing Access Criteria
Any
Learn more about this trial
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery
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