Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

Phase 3

Completed

• Conditions: Labor Pain
• Interventions: Other: Sterile water; Drug: (1) Paracetamol injection

• Registration Number: NCT01428375
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(2) Placbo (Sterile water) arm: n=60	Sterile water	Sterile water
(1) Active (Paracetamol) arm: n=60	(1) Paracetamol injection	(Paracetamol)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt