Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

Study Overview
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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

Official Title
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Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial

Conditions
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Prevention of Postoperative Ileus

Intervention / Treatment
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* Drug: Mosapride
* Drug: Placebo Oral Tablet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mouth dissolving mosapride<br>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<br>* Intake mouthly dissolving mosapride tablets in immediate post cesarean section<br>* Other names: Fluxopride;|
| Placebo Comparator: Placebo mouth dissolving tablets<br>Dummy identical tablets taken in the same way | Drug: Placebo Oral Tablet<br>* Dummy identical tablets to mouthly dissolving mosapride tablets<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of first flatus | Clinical | 96 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paralytic ileus incidence and its severity | Clinical | 7days | 
| Toleration of fluids and solids intake | Clinical | 2 weeks postoperative | 
| Incidence of intraoperative and postoperative nausea and vomiting | Clinical | Intraoperative and 2 weeks postoperative | 
| First defecation | Clinical | 2 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative vomiting, Postoperative ileus, mosapride, mouth dissolving tablets