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

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
      • 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:
  • Fluxopride
Placebo Comparator: Placebo mouth dissolving tablets
Dummy identical tablets taken in the same way
Dummy identical tablets to mouthly dissolving mosapride tablets
Other Names:
  • Placebo

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.

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

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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