| CTRI Number |
CTRI/2022/04/042227 [Registered on: 27/04/2022] Trial Registered Prospectively |
| Last Modified On: |
26/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of inj metoclopramide given intravenously on gastric emptying in pregnant women in labour undergoing induction trial using sonography |
|
Scientific Title of Study
|
Effect of intravenous metoclopramide on rate of gastric emptying and time to achieve critical gastric volume in parturients undergoing induction trial using serial antral ultrasonography: A randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Omprakash Gaure |
| Designation |
PG Student |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8982441156 |
| Fax |
|
| Email |
omprakashgaure07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
Professor |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
Professor |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhimrao Ambedkar Memorial Hospital, Raipur |
|
|
Primary Sponsor
|
| Name |
Dr Pratibha Jain Shah |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pratibha Jain Shah |
Dr Bhimrao Ambedkar Memorial Hospital RaipurPt |
Department of Anaesthesiology Pt JNM Medical College, Jail road, Raipur
Raipur
CHHATTISGARH |
9827276620
prati_jain@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. JNM Medical College Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Metoclopramide |
Inj Metoclopramide 10 mg iv single dose |
| Comparator Agent |
normal saline |
normal saline 2 ml iv single dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
singleton term pregnant women undergoing induction trial with
ASA physical status II
BMI<35 kg/m2
|
|
| ExclusionCriteria |
| Details |
1. patient refusal
2.Baseline critical gastric volume < 1.5 ml/ kg
3.Patient with ryles tube in situ
4.Hyperemesis gravidarum
5.Gastroparesis
6.Autonomic disorder
7.Gastrointestinal disease
8.medications which alters gastric emptying time
9.Novel CORONA virus positivity
10.Known history of substance abuse or alcohol abuse/allergy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| rate of gastric emptying following intravenous metoclopramide and normal saline by serial uitrasonography |
every 10 minutes after giving injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to achieve critical gastric volume
Correlation between qualitative sonographic evaluation and rate of gastric emptying
Correlation between qualitative sonographic evaluation and time to achieve critical gastric volume
|
every 10 minutes after giving injection |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a interventional double blinded study to study the effect of metoclopramide on rate of gastric emptying and time to achieve critical gastric volume in parturients undergoing induction trial using serial ultrasonography aged 18 to 40 years with ASA grade II. It will be conducted at single centre in India. the primary outcome will be rate of gastric emptying time following iv metoclopramide and normal saline and secondary outcomes will be time to achieve critical gastric volume, correlation between qualitative sonographic evaluation and rate of gastric emptying and time to achieve critical gastric volume after intravenous metoclopramide and normal saline. |