Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 2012

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

Arms, Groups and Cohorts

  • Active Comparator: (1) Active (Paracetamol) arm: n=60
    • (Paracetamol)
  • Placebo Comparator: (2) Placbo (Sterile water) arm: n=60
    • Sterile water

Clinical Trial Outcome Measures

Primary Measures

  • To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
    • Time Frame: 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 Measures

  • To document safety
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Elsayed Hassan Elbohoty, Lecturer in OB GYN – Ain Shams University
  • Overall Official(s)
    • Ahmed E Elbohoty, MD, Principal Investigator, OB GYN Department, faculty of Medicine, ASU

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.