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Oral Paracetamol as Preemptive Analgesia for Labor Pain

Phase 3
Completed
Conditions
Labor Pain
Interventions
Drug: placebo
Registration Number
NCT01817829
Lead Sponsor
Ain Shams University
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
placeboplaceboplacebo 2 tablets containing Starch PO
paracetamolparacetamolparacetamol 2 tablets1000mg PO.
Primary Outcome Measures
NameTimeMethod
Efficacyintrapartum

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 Outcome Measures
NameTimeMethod
SafetyStart of medication till 24 hours postpartum

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

Duration of laborStart of medication till delivery of fetus.

To assess the effect of the duration of labor.

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