| CTRI Number |
CTRI/2018/05/014020 [Registered on: 21/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
painless delivery |
|
Scientific Title of Study
|
Comparison of intravenous Paracetamol versus intravenous Tramadol for analgesia in labour |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EKTA |
| Designation |
PG resident |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana
Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana
Sonipat
HARYANA
131301
India |
| Phone |
8958047267 |
| Fax |
|
| Email |
drektasidhu1641@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUNITA SIWACH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women |
| Address |
BAHAGAT PHOOL SINGH GGOVT MEDICAL COLLEGE FOR WOMEN, KHANPUR KALAN , SONIPAT, HARYANA
Sonipat
HARYANA
131301
India |
| Phone |
9812266400 |
| Fax |
|
| Email |
siwachsunita@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
EKTA SIDHU |
| Designation |
PG resident |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana
Sonipat
HARYANA
131301
India |
| Phone |
8958047267 |
| Fax |
|
| Email |
drektasidhu1641@gmail.com |
|
|
Source of Monetary or Material Support
|
| BPS GMC, Khanpur Kalan, Sonepat, Haryana |
|
|
Primary Sponsor
|
| Name |
BPS Government medical college |
| Address |
BPS Government Medical College, Khanpur Kalan, Sonepat, Haryana |
| 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 |
| EKTA |
Bhagat Phool Singh Goovernment Medical College for women |
LABOUR ROOM COMPLEX OF DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Sonipat
HARYANA |
8958047267
drektasidhu1641@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BPS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant women in active stage of labour, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Paracetamol |
single dose of 100 ml of 1000 mg Paracetamol will be given intravenously over 15 min during active stage of labour |
| Comparator Agent |
Tramadol |
single dose of 100 mg Tramadol in 100 ml of 0.9% normal saline will be given intravenously over 15 min during active stage of labour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Primigravid and multigravid women of age ranges from 18 to 35 years with low risk to both mother and fetus (single live fetus in cephalic presentation without any associated obstetric and medical complication)
2. Women with gestational age ranges from 37 to 42 weeks
3. Women in active stage of labour (with cervical dilatation of 3-5 cm and with moderate intensity uterine contractions of 2-3 per 10 minutes each lasting for 30-45 seconds with good inter relaxation period in between), whether spontaneous or induced labour
4. Women with reactive Non Stress Test (NST) before recruitment into study
5. Women seeking labour analgesia
|
|
| ExclusionCriteria |
| Details |
1. Women with high risk pregnancy like severe Intrauterine growth retardation (IUGR), multiple gestation, malpresentation, polyhydroamnios, oligohydroamnios, pre-mature rupture of membranes
2. Women with any medical disorder with pregnancy like severe anaemia, hypertensive disorders, diabetes mellitus, hypothyroidism
3. Women with scarred uterus
4. Women with obstetric indication for Lower Segment Caesarean Section before recruitment to study
5. Women in advanced stage of labour if cervical dilatation more than 5 cm
6. Women with use of any other kind of analgesia before recruitment to study
7. Women with previous history of hypersensitivity to Tramadol or Paracetamol
8. Women with deranged liver function test
9. Women not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VISUAL ANALOGUE SCALE score |
At 0, 1/2, 1, 2 and 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic Profile of patients |
At 0 hour |
| Duration of labour analgesia |
At 0, 1/2, 1, 2 and 4 hours |
| Duration of active phase of labour |
After delivery |
| Effect on progress of labour |
At 0, 1/2, 1, 2 and 4 hours |
| Mode of delivery |
After delivery |
| Effect on fetus during labour |
At 0, 1/2, 1, 2 and 4 hours |
| APGAR SCORE |
At 1 and 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
01/02/2018 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
NON YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
INTRODUCTION- Labour analgesia is an essential part of good obstetric care. Though labour pain is not life threatening, it can have neuropshychological consequences.Tramadol inhibits serotonin and norepinephrine uptake and enhance the inhibitory effects of pain transmission in the spinal cord. Tramadol and its metabolites are mainly excreted via the kidneys. Pracetamol is an effective analgesic with tolerable side effects. The use of intravenous formulation during labour for pain relief is advantageous with improved bioavailability and earlier onset of action. Its plasma half life is about 2.7 hours.
AIMS AND OBJECTIVES- To provide labour analgesia in form of intravenous Paracetamol and Tramadol during active stage of labour with following objectives- 1) To study the safety and efficacy of intravenous Pararcetamol and Tramadol for labour analgesia 2) Comparison of intravenous paracetamol and tramadol for labour analgesia
PROCEDURE TO BE DONE- To 125 women 100ml of Pracetamol will be given intravenously over 15 minutes and to 125 women 100ml of Tramadol will be given intravenously over 15 minutes and grading of labour analgesia will be recorded by Visual analogue scale score (VAS) between 0 and 10 ( 0= no pain and 10= most severe pain) at time of intervention and at 1/2 hour ,1 hour, 2 hour and 4 hour. |