Labor Pain
Conditions
Keywords
intravenous paracetamol, intrapartum analgesia, labor pain, intrapartum pains
Brief summary
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
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.
Interventions
DRUG(1) Paracetamol injection
Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion
OTHERSterile water
Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18-35 years. 2. Primigravida. 3. The gestational age between 37- 42 weeks. 4. Patient seeking analgesia. 5. Single viable fetus. 6. Vertex presentation. 7. Spontaneous onset of labor. 8. 1st stage of labor with cervical dilatation 3-4 cm ( in active phase).
Exclusion criteria
1. Extreme of age (below 18-above 35). 2. Multiparity. 3. Multiple gestation. 4. Malpresentation. 5. Major degree of cephalopelvic disproportion. 6. Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia. 7. Induction of labor. 8. Cervical dilatation exceeds exceeding 4 cm. 9. Use of any other kind of analgesia before recruitment in the study. 10. Scared uterus. 11. Fetal distress. 12. Antepartum hemorrhage. 13. Intrapartum bleeding. 14. Polyhydramnios. 15. Pre-mature rupture of membranes. 16. Intra uterine infections. 17. Hypersensitivity to paracetamol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women | 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. | By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To document safety | Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours. | By assessing the adverse events recorded during the study either maternal or fetal/neonatal. |
| To correlate with the duration of labor | 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. | The difference between both groups regarding labour duration |
Countries
Egypt
Outcome results
None listed