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Completed

NCT Number: NCT01817829

Oral Paracetamol as Preemptive Analgesia for Labor Pain

It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primigravida
  • The gestational age between 37- 42 weeks
  • Not seeking analgesia
  • Singleton pregnancy
  • vertex
  • Spontaneous onset of labour
  • 1st stage of labour (less than 5 cm)

Exclusion criteria

  • Extreme of age (below18-above 40)
  • Multiparous
  • Multiple gestation
  • Malpresentation
  • Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)
  • Any medical disorder with pregnancy
  • Induction of labour
  • Advanced 1st stage > 5 cm
  • Use of any other kind of analgesia before recruitment in the study
  • Scared uterus
  • Fetal distress

Treatment and study plan

Paracetamol

Drug

500 mg oral tablet

Placebo

Drug

Primary outcomes

  1. Efficacy

    Time frame: intrapartum

    To document the efficacy of oral paracetamol, in pregnant women in labor, as demonstrated by the degree of pain relief and need for additional analgesia during the labor process and the early postpartum period.

Secondary outcomes

  1. Safety

    Time frame: Start of medication till 24 hours postpartum

    To document safety and evaluate adverse events recorded during the study either maternal or fetal.

  2. Duration of labor

    Time frame: Start of medication till delivery of fetus.

    To assess the effect of the duration of labor.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2013
Registry last updated
Mar 26, 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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