NCT04290026

Brief Summary

Ultrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section study

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

February 24, 2020

Last Update Submit

July 19, 2021

Conditions

Aspiration Vomitus

Outcome Measures

Primary Outcomes (1)

  • 1. The size of the cross-sectional antral area

    G-0: Antrum was flat and empty in a supine and right lateral position G-1: Antrum had fluid in the right lateral position but empty in the supine position G-2: Antrum had fluid and food in both the supine and right lateral position.

    Immediately after the procedure

Secondary Outcomes (1)

  • The incidence of post operative nausea or vomiting and the effects on the hemodynamic status

    1day

Study Arms (1)

metoclopramide versus granisetron

ACTIVE COMPARATOR

Ultrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section: A randomized, double-blind, placebo-controlled study

Drug: metoclopramide versus granisetron

Interventions

metoclopramide versus granisetronDRUG

ِِِِAssessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section by us

metoclopramide versus granisetron

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients undergoing caesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women
  • Age :18-45
  • Informed consent

You may not qualify if:

  • women who have a history of :
  • diabetes mellitus
  • hypertension
  • preeclampsia
  • neurological and psychological disorders
  • renal or hepatic diseases
  • chronic Gerd
  • refusal to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal RefluxGastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiratory AspirationRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • saeid metwally

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohamed Ahmed

CONTACT

0201060207238mohamedelkhatib90@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent lecturer

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 28, 2020

Study Start

April 1, 2021

Primary Completion

January 31, 2022

Study Completion

April 1, 2022

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share
Time Frame
3 years
Access Criteria
age, sex ,clinical diagnosis

Locations

EG(1)