Clinical Trial: Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Ain Shams University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Ain Shams University

Dates:
Date Received: August 15, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 4, 2013
Last Verified: February 2013