Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

Study Overview
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Brief Summary
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This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.

Detailed Description
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Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.

Official Title
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Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: (1) Paracetamol injection
* Other: Sterile water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-35 years. Primigravida. The gestational age between 37- 42 weeks. Patient seeking analgesia. Single viable fetus. Vertex presentation. Spontaneous onset of labor. 1st stage of labor with cervical dilatation 3-4 cm ( in active phase). Exclusion Criteria: Extreme of age (below 18-above 35). Multiparity. Multiple gestation. Malpresentation. Major degree of cephalopelvic disproportion. Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia. Induction of labor. Cervical dilatation exceeds exceeding 4 cm. Use of any other kind of analgesia before recruitment in the study. Scared uterus. Fetal distress. Antepartum hemorrhage. Intrapartum bleeding. Polyhydramnios. Pre-mature rupture of membranes. Intra uterine infections. Hypersensitivity to paracetamol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (1) Active (Paracetamol) arm: n=60<br>(Paracetamol) | Drug: (1) Paracetamol injection<br>* Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion<br>|
| Placebo Comparator: (2) Placbo (Sterile water) arm: n=60<br>Sterile water | Other: Sterile water<br>* Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women | By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process. | Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document safety | By assessing the adverse events recorded during the study either maternal or fetal/neonatal. | Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours. | 
| To correlate with the duration of labor | The difference between both groups regarding labour duration | Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous paracetamol, intrapartum analgesia, labor pain, intrapartum pains