Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

Prevention of Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477266
• Other study ID #: Ashrafnassif2002@yahoo.com
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• all women undergoing elective cesarean section

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Prevention of Postoperative Ileus

Intervention

Drug:
• Mosapride
Intake mouthly dissolving mosapride tablets in immediate post cesarean section
• Placebo Oral Tablet
Dummy identical tablets to mouthly dissolving mosapride tablets

Locations

Country	Name	City	State
Egypt	Ashraf nassif Elmantwe	Banha	Elqalopia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of first flatus	Clinical	96 hours postoperative
Secondary	Paralytic ileus incidence and its severity	Clinical	7days
Secondary	Toleration of fluids and solids intake	Clinical	2 weeks postoperative
Secondary	Incidence of intraoperative and postoperative nausea and vomiting	Clinical	Intraoperative and 2 weeks postoperative
Secondary	First defecation	Clinical	2 weeks postoperative