| CTRI Number |
CTRI/2018/09/015751 [Registered on: 18/09/2018] Trial Registered Prospectively |
| Last Modified On: |
29/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
HEADING TOWARDS BETTERMENT OF PAINLESS DELIVERY OF PREGNANT WOMEN. |
|
Scientific Title of Study
|
Intravenous dexamethasone as an adjunct to epidural labour analgesia with 0.125% ropivacaine in parturients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagdish kumar |
| Designation |
POST GRADUATE STUDENT IN ANAESTHESIOLOGY |
| Affiliation |
DR SNMC JODHPUR, RAJASTHAN |
| Address |
DEPARTMENT OF ANAESTHESIA,
DR SNMC, JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
7792009237 |
| Fax |
|
| Email |
drkumawat2084@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHOBHA UJWAL |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
DR SNMC, JODHPUR |
| Address |
DEPARTMENT OF ANAESTHESIA,
DR SNMC, JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9461028789 |
| Fax |
|
| Email |
drshobhaujwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHOBHA UJWAL |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
DR SNMC, JODHPUR |
| Address |
DEPARTMENT OF ANAESTHESIA, DR SNMC, JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
|
| Fax |
|
| Email |
drshobhaujwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR S.N. MEDICAL COLLEGE JODHPUR, RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jagdish kumar |
MDM HOSPITAL, JODHPUR |
LABOUR ROOM,ZANANA WING MDM HOSPITAL.
JODHPUR
Jodhpur
RAJASTHAN |
7792009237
drkumawat2084@gmail.com |
| Dr JAGDISH KUMAR |
UMAID HOSPITAL |
LABOUR ROOM,UMAID HOSPITAL,JODHPUR
Barmer
RAJASTHAN |
7792009237
drkumawat2084@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| dr SNMC ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parturients asa 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C- Control(placebo) group |
The group C will receive 50 ml of plain normal saline only. |
| Intervention |
Group D- Dexamethasone group |
The test drug will be prepared by adding 8 mg of dexamethasone to normal saline( total volume 50 ml) and this will be given to the patient intravenously over 15 min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Parturients in established labour with cervical dilation >3cm, with intact or absent membranes and having satisfactory uterine contractions with >50% effacement.
2.Singleton pregnancy with vertex presentation at term,
3.Primigravidaor gravida 2 (previously normal delivered),
4.Age 18 years or above, weight less than 100kg, height 150 cm or more.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal,
2.Any fetal anomalies,
3.History of coagulation disorders,
4.Any contraindications to epidural anaesthesia,
5.History of allergy to local anaesthetics,
6.Any obstetric complications (e.g., premature rupture of amniotic membranes,PIH),
7.Systemic and local sepsis,
8.Parturients having multiple pregnancies and premature labour,
9.History of peptic ulcer disease,
10.Known case of uncontrolled diabetes mellitus, and patient who had received dexamethasone in last 7 days for fetal lung maturity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate hourly average consumption of neuraxially administered ropivacaine for duration of epidural labour analgesia. |
hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain score(VAS SCORING),
2.Maternal satisfaction,
3.Sensory and motor block characteristics,
4.Hemodynamic parameters of mother,
5.Fetal heart rate(FHR),
6.Duration of second stage of labor,
7.Mode of delivery,
8.Apgar scores at 1 and 5 min, and
9.Adverse effects |
NA |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2018 |
| Date of Study Completion (India) |
31/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
80 PARTURIENTS DEMANDING LABOUR ANALGESIA, WILL BE TAKEN FOR STUDY. THE PARTURIENTS WILL BE RANDOMIZED INTO TWO GROUPS BY COMPUTER GENERATED RANDOMIZATION METHOD. GROUP D WILL GET IV DEXAMETHASONE PRIOR TO EPIDURAL ANALGESIA OTHER GROUP IS CONTROLL GROUP,MATERNAL SATISFICATION WILL BE COMPARED. |