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Oral Paracetamol as Preemptive Analgesia for Labor Pain

Primary Purpose

Labor Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
paracetamol
placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    paracetamol

    placebo

    Arm Description

    paracetamol 2 tablets1000mg PO.

    placebo 2 tablets containing Starch PO

    Outcomes

    Primary Outcome Measures

    Efficacy
    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

    Safety
    To document safety and evaluate adverse events recorded during the study either maternal or fetal.
    Duration of labor
    To assess the effect of the duration of labor.

    Full Information

    First Posted
    February 4, 2013
    Last Updated
    March 21, 2013
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01817829
    Brief Title
    Oral Paracetamol as Preemptive Analgesia for Labor Pain
    Official Title
    Oral Paracetamol as Preemptive Analgesia for Labor Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    paracetamol
    Arm Type
    Active Comparator
    Arm Description
    paracetamol 2 tablets1000mg PO.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo 2 tablets containing Starch PO
    Intervention Type
    Drug
    Intervention Name(s)
    paracetamol
    Intervention Description
    500 mg oral tablet
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Efficacy
    Description
    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.
    Time Frame
    intrapartum
    Secondary Outcome Measure Information:
    Title
    Safety
    Description
    To document safety and evaluate adverse events recorded during the study either maternal or fetal.
    Time Frame
    Start of medication till 24 hours postpartum
    Title
    Duration of labor
    Description
    To assess the effect of the duration of labor.
    Time Frame
    Start of medication till delivery of fetus.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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