Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

NCT03477266 | Completed Phase 3

• 1 other identifier: Ashrafnassif2002@yahoo.com
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Prevention of Postoperative Ileus

Keywords

Postoperative ileus; mosapride; mouth dissolving tablets; Intraoperative vomiting

Outcome Measures

Primary Outcomes (1)

• Time of first flatus

  Clinical

  96 hours postoperative

Secondary Outcomes (4)

• Paralytic ileus incidence and its severity

  7days

• Toleration of fluids and solids intake

  2 weeks postoperative

• Incidence of intraoperative and postoperative nausea and vomiting

  Intraoperative and 2 weeks postoperative

• First defecation

  2 weeks postoperative

Study Arms (2)

Mouth dissolving mosapride

EXPERIMENTAL

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 mouth dissolving tablets

PLACEBO COMPARATOR

Dummy identical tablets taken in the same way

Drug: Placebo Oral Tablet

Interventions

Mosapride DRUG

Intake mouthly dissolving mosapride tablets in immediate post cesarean section

Also known as: Fluxopride

Mouth dissolving mosapride

Placebo Oral Tablet DRUG

Dummy identical tablets to mouthly dissolving mosapride tablets

Also known as: Placebo

Placebo mouth dissolving tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: After cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• all women undergoing elective cesarean section

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ashraf nassif Elmantwe

Banhā, Elqalopia, Egypt

Location

MeSH Terms

Interventions

mosapride

Study Officials

• Ashraf N Elmantwe, MD

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 26, 2018
• Study Start: April 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When data became available and for ever
• Access Criteria: Any

Locations

EG (1)