Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428375
• Other study ID #: PARACETAMOL-INTRAPARTUM
• Secondary ID: PARACETAMOL-INTR
• Status: Completed
• Phase: Phase 3
• First received: August 15, 2011
• Last updated: February 4, 2013
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ain Shams College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• (1) Paracetamol injection
Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion

Other:
• Sterile water
Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes
Secondary	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.	No