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Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT03477266
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
4
Actual Duration (Months)
99.8
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes 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
Primary Purpose:
Prevention
Official Title:
Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

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

Drug: Mosapride
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

    Drug: Placebo Oral Tablet
    Dummy identical tablets to mouthly dissolving mosapride tablets
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time of first flatus [96 hours postoperative]

      Clinical

    Secondary Outcome Measures

    1. Paralytic ileus incidence and its severity [7days]

      Clinical

    2. Toleration of fluids and solids intake [2 weeks postoperative]

      Clinical

    3. Incidence of intraoperative and postoperative nausea and vomiting [Intraoperative and 2 weeks postoperative]

      Clinical

    4. First defecation [2 weeks postoperative]

      Clinical

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all women undergoing elective cesarean section
    Exclusion Criteria:
    • prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ashraf nassif Elmantwe Banha Elqalopia Egypt

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Principal Investigator: Ashraf N Elmantwe, MD, Benha University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ashraf nassif mahmoud elmantwe,MD, Assistant professor, Benha University
    ClinicalTrials.gov Identifier:
    NCT03477266
    Other Study ID Numbers:
    • Ashrafnassif2002@yahoo.com
    First Posted:
    Mar 26, 2018
    Last Update Posted:
    Aug 14, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by ashraf nassif mahmoud elmantwe,MD, Assistant professor, Benha University
    Postoperative ileus
    mosapride
    mouth dissolving tablets
    Intraoperative vomiting
    Additional relevant MeSH terms:
    Ileus
    Mosapride

    Study Results

    No Results Posted as of Aug 14, 2018