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Oral Paracetamol as Preemptive Analgesia for Labor Pain

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ClinicalTrials.gov Identifier: NCT01817829
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : March 26, 2013
Sponsor:
Information provided by (Responsible Party):
Ahmed Elsayed Hassan Elbohoty, Ain Shams University

Study Description
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Brief Summary:
It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: paracetamol Drug: placebo Phase 3

Detailed Description:
It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Oral Paracetamol as Preemptive Analgesia for Labor Pain
Study Start Date : December 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: paracetamol
paracetamol 2 tablets1000mg PO.
 Drug: paracetamol
500 mg oral tablet
Placebo Comparator: placebo
placebo 2 tablets containing Starch PO
 Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Ahmed Elsayed Hassan Elbohoty, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT01817829    
Other Study ID Numbers: OPPALP
Personal ( Other Identifier: Ain Shams )
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Acetaminophen
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics