| CTRI Number |
CTRI/2018/09/015594 [Registered on: 05/09/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of the efficacy of MgSO4 on labour analgesia |
|
Scientific Title of Study
|
Evaluation of the efficacy of MgSO4 as an adjunct to ropivacaine and fentanyl for labour analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indira Kumari |
| Designation |
Senior Professor and Head |
| Affiliation |
RNT Medical College |
| Address |
Department of Anaesthesiology, RNT Medical College
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Kumari |
| Designation |
Senior Professor and Head |
| Affiliation |
RNT Medical College |
| Address |
Department of Anaesthesiology, RNT Medical College
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Gupta |
| Designation |
Junior Resident |
| Affiliation |
RNT Medical College |
| Address |
Department of Anaesthesiology, RNT Medical College
Udaipur
RAJASTHAN
313001
India |
| Phone |
8955074146 |
| Fax |
|
| Email |
docmeghagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.N.T Medical College, Udaipur |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
R.N.T. Medical College, Udaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Indira Kumari |
Obstetrics & Gynaecology operation theatre |
Department of Anaesthesiology, RNT Medical College
Udaipur
RAJASTHAN |
9414176760
dr_ikumari@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R.N.T. Medical College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Primigravida , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
epidural catheter inserted and drug is not administered |
| Intervention |
Ropivacaine plus fentanyl |
7.5ml 0.2% Ropivacaine with 1mcg/kg fentanyl given via epidural catheter |
| Intervention |
Ropivacaine plus fentanyl plus MgSO4 |
7.5ml 0.2% Ropivacaine with 1mcg/kg fentanyl plus 50mg MgSO4 given via epidural catheter |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primi parturients
In active labour requesting labour analgesia |
|
| ExclusionCriteria |
| Details |
Parturient refusal
Coagulopathy
Infection at puncture site
Hypersensitivity to study drugs
pregnancy induced hypertension
Breech presentation
Multiparity
Gestational diabetes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the adjuvant effect of single dose MgSO4 administered epidurally with ropivacaine and fentanyl for labour analgesia |
5mins, 10mins, 15mins, 30mins, 60mins and 1hrly uptil time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of MgSO4 on neonatal outcome |
5mins, 10mins, 15mins, 30mins, 60mins and 1hrly uptil time of delivery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, prospective, double blind unmatched study to evaluate the effect of MgSO4 administered epidurally as an adjunct to ropivacaine and fentanyl for labour analgesia. According to the study, MgSO4 prolongs the duration of analgesia. |