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CompletedNCT03477266Updated Aug 14, 2018

Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

A Phase 3 interventional study of Mosapride and Placebo Oral Tablet in Prevention of Postoperative Ileus, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by Benha University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Prevention of Postoperative Ileus

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Keywords

  • Postoperative ileus
  • mosapride
  • mouth dissolving tablets
  • Intraoperative vomiting
03

In context

Ileus

167 studies on the registry are indexed under Ileus; 23 are open to participants now.

This study's enrollment of 400 is above the median of 90 across 138 interventional studies indexed under Ileus.

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Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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Inclusion criteria

  • all women undergoing elective cesarean section

Exclusion criteria

Exclusion Criteria:

  • prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo mouth dissolving tablets

    Dummy identical tablets taken in the same way

    Drug: Placebo Oral Tablet

Interventions

  • Intake mouthly dissolving mosapride tablets in immediate post cesarean section

    Also known as: Fluxopride

  • DrugPlacebo Oral Tablet

    Dummy identical tablets to mouthly dissolving mosapride tablets

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Time of first flatus

    Clinical

    Time frame: 96 hours postoperative

Secondary outcomes

  1. Paralytic ileus incidence and its severity

    Clinical

    Time frame: 7days

  2. Toleration of fluids and solids intake

    Clinical

    Time frame: 2 weeks postoperative

  3. Incidence of intraoperative and postoperative nausea and vomiting

    Clinical

    Time frame: Intraoperative and 2 weeks postoperative

  4. First defecation

    Clinical

    Time frame: 2 weeks postoperative

07

Study locations

1 site
  • Ashraf nassif Elmantwe
    Banha, Elqalopia, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — Once data collected and analyzed and published

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: When data became available and for ever

Access criteria: Any

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477266
Lead sponsor
Benha University
Responsible party
ashraf nassif mahmoud elmantwe,MD (Assistant professor, Benha University) — Principal investigator
First posted
Mar 26, 2018
Start date
Apr 1, 2018
Primary completion
Jun 1, 2018
Completion
Aug 1, 2018
Last update
Aug 14, 2018

Study contacts

Ashraf N Elmantwe, MD
principal investigator · Benha University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Mosapride

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