SE OF PARACETAMOL AS LABOUR ANALGESIC

Phase 3

Conditions: abour pain.
Delivery
080.0

Registration Number: IRCT20220308054220N1

Lead Sponsor: Public sector medical college Rawalpindi Pakistan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 130

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.