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IRCT20220308054220N1 IRCT 2022-04-04 Public sector medical college Rawalpindi Pakistan USE OF PARACETAMOL AS LABOUR ANALGESIC EFFICACY OF PARENTERAL ACETAMINOPHEN AS INTRAPARTUM ANALGESIC 2022-05-15 anticipated 130 Complete https://irct.ir/trial/62380 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Labour pain. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: title: Results. Tables and graphs of primary outcome and secondary outcome will be shared. When: it will be given in the duration of 10 months to 36 months after publishing. It will be available lifelong To whom: everyone Conditions: everyone who want to take advantage of this trial results will be allowed for the service of humanity. Where to obtain: they can talk to principal investigator of this trial Wajeha Najeeb. E-mail: wajeha.najeeb@hotmail.com How to obtain: email Comments:
public Wajeha najeeb
Abid majeed road Rawalpindi Pakistan
Rawalpindi Pakistan 46000 +92 333 0335060 wajeha.najeeb@hotmail.com Public sector medical college Rawalpindi Pakistan scientific Wajeha najeeb
Abid majeed road Rawalpindi Pakistan
Rawalpindi Pakistan 46000 +92 333 0335060 wajeha.najeeb@hotmail.com Public sector medical college Rawalpindi Pakistan Pakistan 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. 18 years 35 years Female 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. 080.0 Delivery Placebo Treatment - Drugs 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. 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. 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. Body mass index. Timepoint: At the start of intervention. Method of measurement: Weight by weighing machine in kgs and height in feet by scale. 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). 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. 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. Complications during delivery. Timepoint: During three stages of labour. Method of measurement: Health care provider will measure using clinical findings. 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. APGAR. Timepoint: At 1 min and 5 min. Method of measurement: APGAR scale. Public sector medical college Rawalpindi Pakistan Approved 2022-03-17 Ethical review committee of Public sector Medical college Abid Majeed Road Rawalpindi Cantt Rawalpindi Punjab Pakistan