- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477266
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery
August 12, 2018 updated by: ashraf nassif mahmoud elmantwe,MD, Benha University
Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 3
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
-
-
Elqalopia
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Banha, Elqalopia, Egypt
- Ashraf nassif Elmantwe
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- all women undergoing elective cesarean section
Exclusion Criteria:
- prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mouth dissolving mosapride
Fluxopride 5mg of Macryrl egypt 2 tablets one day before and immediately after elective cesarean section every 8hour for maximum of 5 days
|
Intake mouthly dissolving mosapride tablets in immediate post cesarean section
Other Names:
|
Placebo Comparator: Placebo mouth dissolving tablets
Dummy identical tablets taken in the same way
|
Dummy identical tablets to mouthly dissolving mosapride tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of first flatus
Time Frame: 96 hours postoperative
|
Clinical
|
96 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Paralytic ileus incidence and its severity
Time Frame: 7days
|
Clinical
|
7days
|
Toleration of fluids and solids intake
Time Frame: 2 weeks postoperative
|
Clinical
|
2 weeks postoperative
|
Incidence of intraoperative and postoperative nausea and vomiting
Time Frame: Intraoperative and 2 weeks postoperative
|
Clinical
|
Intraoperative and 2 weeks postoperative
|
First defecation
Time Frame: 2 weeks postoperative
|
Clinical
|
2 weeks postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2018
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
February 21, 2018
First Submitted That Met QC Criteria
March 23, 2018
First Posted (Actual)
March 26, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2018
Last Update Submitted That Met QC Criteria
August 12, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ashrafnassif2002@yahoo.com
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
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
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.
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