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NCT Number: NCT01428375

Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

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

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-35 years.
  • Primigravida.
  • The gestational age between 37- 42 weeks.
  • Patient seeking analgesia.
  • Single viable fetus.
  • Vertex presentation.
  • Spontaneous onset of labor.
  • 1st stage of labor with cervical dilatation 3-4 cm ( in active phase).

Exclusion criteria

  • Extreme of age (below 18-above 35).
  • Multiparity.
  • Multiple gestation.
  • Malpresentation.
  • Major degree of cephalopelvic disproportion.
  • Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
  • Induction of labor.
  • Cervical dilatation exceeds exceeding 4 cm.
  • Use of any other kind of analgesia before recruitment in the study.
  • Scared uterus.
  • Fetal distress.
  • Antepartum hemorrhage.
  • Intrapartum bleeding.
  • Polyhydramnios.
  • Pre-mature rupture of membranes.
  • Intra uterine infections.
  • Hypersensitivity to paracetamol.

Treatment and study plan

(1) Paracetamol injection

Drug

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

Sterile Water

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 5, 2011
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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