| CTRI Number |
CTRI/2016/04/006888 [Registered on: 28/04/2016] Trial Registered Prospectively |
| Last Modified On: |
27/04/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of analgesia during labour on post partum depression |
|
Scientific Title of Study
|
Effect of combined spinal-epidural analgesia during labour on post partum depression: a 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 Amrit Kaur |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
|
| Address |
Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9501415120 |
| Fax |
|
| Email |
kauramrita.25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrit Kaur |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
|
| Address |
Department of Anaesthesia and Intensive care Government Medical college and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9501415120 |
| Fax |
|
| Email |
kauramrita.25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Government Medical College and Hospital Sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amrit Kaur |
Labour room Operation theatre and Labour room |
Clean labour room Level 1 A-block Government Medical college and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH |
9501415120
kauramrita.25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH CHANDIGARH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA Grade 1 and 2 parturients more than 18 years of age who give consent for labour analgesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Combined Spinal Epidural Group |
Parturients belonging to group 1 will receive neuraxial block using combined spinal epidural technique and evaluated for post partum depression at day 3 and 6 weeks using Edinburgh postnatal depression scale(EPDS) |
| Comparator Agent |
Group 2- Normal Vaginal Delivery Group |
Parturients belonging to group 2 will be evaluated for post partum depression at day 3 and 6 weeks using Edinburgh postnatal depression scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade 1 and 2
Age more than 18 years
Primigravida Single gestation
Cephalic presentation at 37 completed weeks of gestation
In early spontaneous labour(cervical dilation < 5cm)
Baseline pain score>30(on a VAS of 0-100)
Able to use PCEA pump
Parturients consenting to participate in the study
|
|
| ExclusionCriteria |
| Details |
Refusal by parturient
Patient failing to understand the functioning of PCEA pump and VAS scoring
History of psychiatric disorder(GHQ12>2)
Obesity(Wt>100kg)
Parturients who have received oral or parenteral analgesics in the last 4 hours
Systemic and local sepsis
Deranged coagulation profile
Preterm labour(<37 commpleted weeks)
Obstetric complications(eg., PROM)
Foetus with a non re-assuring NST
Foetus with known or suspected congenital anomalies
Allergy to study drugs i.e., levobupivacaine, fentanyl
Patient with Diabetes(pre-existing or gestational) or history of immunosuppression.
Patients with hypertension on methyldopa
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence(frequency in percentage) of post partum depression using EPDS questionnaire |
Day 3 and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal satisfaction(VAS score)
Pain score(VAS score)
Sensory and motor block characteristics
Haemodynamic parameters of mother
Foetal heart rate
Duration of 2nd stage of labour
Mode of delivery
Apgar scores
Adverse effects
|
Till delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
01/09/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, prospective,open labled trial to evaluate the effect of combined spinal epidural analgesia during labour on post partum depression.The index group receiving the neuraxial block would be compared with the control normal vaginal delivery group for post partum depression, using the Edinburgh postnatal depression scale(EPDS) at 3 days and 6 weeks. The primary outcome measure would be prevalence(frequency in percentage) of post partum depression using EPDS questionnaire. The secondary outcome and observational measures would include Maternal satisfaction( based on score of Visual Analog scale), Pain score(VAS Score), Sensory and motor block characteristics, Haemodynamic parameters of mother, Foetal heart rate, Duration of second stage of labour, Mode of delivery, Apgar scores and adverse effects. |