NCT01817829

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

6 months

First QC Date

February 4, 2013

Last Update Submit

March 21, 2013

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    intrapartum

Secondary Outcomes (2)

  • Safety

    Start of medication till 24 hours postpartum

  • Duration of labor

    Start of medication till delivery of fetus.

Study Arms (2)

paracetamol

ACTIVE COMPARATOR

paracetamol 2 tablets1000mg PO.

Drug: paracetamol

placebo

PLACEBO COMPARATOR

placebo 2 tablets containing Starch PO

Drug: placebo

Interventions

paracetamolDRUG

500 mg oral tablet

paracetamol
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 4, 2013

First Posted

March 26, 2013

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 26, 2013

Record last verified: 2013-03