Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

NCT ID: NCT03477266

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-08-01

Brief Summary

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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

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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

Conditions

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Prevention of Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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

Study Groups

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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

Group Type EXPERIMENTAL

Mosapride

Intervention Type DRUG

Intake mouthly dissolving mosapride tablets in immediate post cesarean section

Placebo mouth dissolving tablets

Dummy identical tablets taken in the same way

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Dummy identical tablets to mouthly dissolving mosapride tablets

Interventions

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Mosapride

Intake mouthly dissolving mosapride tablets in immediate post cesarean section

Intervention Type DRUG

Placebo Oral Tablet

Dummy identical tablets to mouthly dissolving mosapride tablets

Intervention Type DRUG

Other Intervention Names

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Fluxopride Placebo

Eligibility Criteria

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Inclusion Criteria

* all women undergoing elective cesarean section

Exclusion Criteria

* prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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ashraf nassif mahmoud elmantwe,MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf N Elmantwe, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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Ashraf nassif Elmantwe

Banhā, Elqalopia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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[email protected]

Identifier Type: -

Identifier Source: org_study_id

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