Oral Paracetamol as Preemptive Analgesia for Labor Pain

March 21, 2013 updated by: Ahmed Elsayed Hassan Elbohoty, Ain Shams University
It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intrapartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Start of medication till 24 hours postpartum
Duration of labor
Time Frame: Start of medication till delivery of fetus.
To assess the effect of the duration of labor.
Start of medication till delivery of fetus.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPPALP
  • Personal (Ain Shams)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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