Therapeutic efficacy of parenteral acetaminophen in relief of labour pain among primigravida.
Attempt to create an impact to make its use more prevalent in our country.
Design
Placebo, double blinded, randomized controlled trial, phase 3, Done by principal investigator using computer generated code,130 participants 65 in each group, group A placebo and group B paracetamol, duration from may to October, 6 months duration.
Settings and conduct
Will be conducted at pharmacology department of Public sector Medical College, National University of Medical Sciences in collaboration with gynecology department Public sector Hospital Rawalpindi Pakistan.
Prticipants, outcome assessor, health care provider will be blinded. Principal investigator is not blinded.by computer generated codes.
Participants/Inclusion and exclusion criteria
Inclusion criteria will be a primigravida of 18–35 year, full-term with uncomplicated spontaneous onset of labour at term (37–42 weeks gestation); singleton pregnancy; cervical dilatation of 3-5 cm and cephalic presentation of fetus.
Exclusion criteria for this research will be malpresentation of fetus; multiparous women; previously scarred uterus; preterm labour; antepartum hemorrhage; history of drug allergy or hypersensitivity; fetal distress (abnormal foetal monitoring during labour); intrauterine foetal death; refusal by parturient; history of alcohol/drug abuse; systemic and local sepsis; deranged coagulation profile; obstetric complications (e.g., premature rupture of amniotic membranes) and women with clinical evidence of cephalopelvic disproportion.
Intervention groups
Group A will serve as control and will receive 100 ml I/V normal saline as placebo whereas group B will receive I/V paracetamol 1000mg in 100ml normal saline at the start of active stage of labour.
Main outcome variables
Pain assessment will be done by VAS scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220308054220N1
Registration date:2022-04-04, 1401/01/15
Registration timing:prospective
Last update:2022-04-04, 1401/01/15
Update count:0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
Wajeha Najeeb
Name of organization / entity
National University of Medical Sciences Pakistan
Country
Pakistan
Phone
+92 333 0335060
Email address
wajeha.najeeb@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-10-30, 1401/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFICACY OF PARENTERAL ACETAMINOPHEN AS INTRAPARTUM ANALGESIC
Public title
USE OF PARACETAMOL AS LABOUR ANALGESIC
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primigravida of 18–35 year.
Full-term with uncomplicated spontaneous onset of labour at term (37–42 weeks gestation).
Singleton pregnancy.
Cervical dilatation of 3-5 cm.
Cephalic presentation of fetus.
Exclusion criteria:
Malpresentation of fetus.
Multiparous women.
Previously scarred uterus (post myomectomy, post cesarean).
Preterm labour.
Antepartum hemorrhage.
History of drug allergy or hypersensitivity.
Fetal distress (abnormal foetal monitoring during labour).
Intrauterine foetal death.
Refusal by parturient.
History of alcohol/drug abuse.
Systemic and local sepsis.
Deranged coagulation profile.
Obstetric complications (e.g., premature rupture of amniotic membranes).
Women with clinical evidence of cephalopelvic disproportion.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by simple randomization. Unit of randomization will be individuals. Tool that will be used in randomization will be computer generated codes. The random sequence of these codes will be built by computer software. The allocation concealment will also be done.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, Health care provider, Person doing intervention, Data collector, Outcome assessor all will be blind. principle investigator, Manuscript writer, Data safety and monitoring board will not be blind. Vial of placebo and paracetamol both will have computer generated code, which will only be decoded by principal investigator.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical review committee of Public sector Medical college
Street address
Abid Majeed Road Rawalpindi Cantt
City
Rawalpindi
Postal code
46000
Approval date
2022-03-17, 1400/12/26
Ethics committee reference number
ERC / ID /196
Health conditions studied
1
Description of health condition studied
Labour pain
ICD-10 code
080.0
ICD-10 code description
Delivery
Primary outcomes
1
Description
Pain assessment
Timepoint
After first dose of paracetamol in Group A and placebo in Group B administration pain will be measured at 15 minutes, 30 minutes, and then at hourly intervals till 4 hours and then readminister the second dose of paracetamol and placebo and then will measure outcome at 15 minutes, 30 minutes, and then at hourly intervals till 4 hours.
Method of measurement
Visual Analogue Scale to measure pain
2
Description
Body mass index
Timepoint
At the start of intervention
Method of measurement
Weight by weighing machine in kgs and height in feet by scale
3
Description
Pulse rate
Timepoint
Before intervention and one time in middle of 4 hours after intervention of first dose and second dose
Method of measurement
Heart rate monitor (HRM)
4
Description
Blood pressure
Timepoint
Before intervention and one time in middle of 4 hours after intervention of first dose and second dose
Method of measurement
Sphygmomonometer
Secondary outcomes
1
Description
Duration of labour
Timepoint
Duration of first stage of labour, duration of second stage, total duration of labour
Method of measurement
Clock to measure time of first and second stage of labour and total duration of labour.
2
Description
Complications during delivery
Timepoint
During three stages of labour
Method of measurement
Health care provider will measure using clinical findings
3
Description
Side-effects after intervention: Nausea, vomiting, sedation, dizziness
Timepoint
During three stages of labour
Method of measurement
Health care provider will measure using clinical findings
4
Description
APGAR
Timepoint
At 1 min and 5 min
Method of measurement
APGAR scale
Intervention groups
1
Description
Control group:In this group placebo, normal saline will be given intravenous to pregnant lady in active labour stage with 3-4 cm cervical dilation and main primary outcomes that is pain is measured at 15 min, 30 min, 1 hour, 2,3,4 hour will be measured. Other primary outcomes are BMI measured by calculating weight by weight machine, pulse meaured by HRM and blood pressure measured by sphygmomanometer before and after giving the dose. Repeat the dose after 4 hour. And again measure the pain , pulse and blood pressure following same pattren of time as for first dose. Pain will measured by VAS ( visual.anslogue scale). Normal saline is 0.9% NaCl. It is 0.9grams of NaCl in 100 ml of water.Dose is 100 ml of normal saline. Secondary outcomes that are duration of labour, Apgar score measured by Apgar scale, complications during delivery will be assessed by person measuring outcomes, side effects after giving dose will be measured by outcome assessor.
Category
Placebo
2
Description
Intervention group: In this group, acetaminophen be given intravenous to pregnant lady in active labour stage with 3-4 cm cervical dilation and main primary outcomes that is pain is measured at 15 min, 30 min, 1 hour, 2,3,4 hour will be measured. Other primary outcomes are BMI measured by calculating weight by weight machine, pulse meaured by HRM and blood pressure measured by sphygmomanometer before and after giving the dose. Repeat the dose after 4 hour. And again measure the pain , pulse and blood pressure following same pattren of time as for first dose. Pain will measured by VAS ( visual.anslogue scale). Both Doses will be same i.e; 1000 mg of acetaminophenin 100ml of normal saline. Secondary outcomes that are duration of labour, Apgar score measured by Apgar scale, complications during delivery will be assessed by person measuring outcomes, side effects after giving dose will be measured by outcome assessor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Public sector hospital rawalpindi pakistan.
Full name of responsible person
Wajeha Najeeb
Street address
Abid Majeed Road Rawalpindi Cantt
City
Rawalpindi
Postal code
46000
Phone
+92 333 0335060
Email
wajeha.najeeb@hotmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Public sector medical college Rawalpindi Pakistan
Full name of responsible person
Mudassar noor
Street address
Abid majeed road Rawalpindi Cantt
City
Rawalpindi
Postal code
46000
Phone
+92 333 3693588
Email
smillingdr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Public sector medical college Rawalpindi Pakistan
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Public sector medical college Rawalpindi Pakistan
Full name of responsible person
Wajeha najeeb
Position
student
Latest degree
A Level or less
Other areas of specialty/work
student of MBBS
Street address
Abid majeed road Rawalpindi Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 0335060
Email
wajeha.najeeb@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Public sector medical college Rawalpindi Pakistan
Full name of responsible person
Wajeha najeeb
Position
student
Latest degree
A Level or less
Other areas of specialty/work
student of MBBS
Street address
Abid majeed road Rawalpindi Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 0335060
Email
wajeha.najeeb@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Public sector medical college Rawalpindi Pakistan
Full name of responsible person
Wajeha najeeb
Position
student
Latest degree
A Level or less
Other areas of specialty/work
student of MBBS
Street address
Abid majeed road Rawalpindi Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 0335060
Email
wajeha.najeeb@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
title: Results. Tables and graphs of primary outcome and secondary outcome will be shared.
When the data will become available and for how long
it will be given in the duration of 10 months to 36 months after publishing. It will be available lifelong
To whom data/document is available
everyone
Under which criteria data/document could be used
everyone who want to take advantage of this trial results will be allowed for the service of humanity.
From where data/document is obtainable
they can talk to principal investigator of this trial Wajeha Najeeb. E-mail: wajeha.najeeb@hotmail.com
What processes are involved for a request to access data/document