NCT01394731

Brief Summary

The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
Last Updated

July 14, 2011

Status Verified

July 1, 2011

Enrollment Period

7 months

First QC Date

July 12, 2011

Last Update Submit

July 13, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS) score for pain

    Patients who give written informed consent to participate will be entered into the study. Their VAS score will be determined every hour from the time of randomization until delivery of the baby. This time will vary from one patient to another depending on the duration of labor.

    Up to 24 hours

Study Arms (3)

Paracetamol 1

EXPERIMENTAL
Drug: Acetaminophen

Paraceatmol 2

EXPERIMENTAL
Drug: Acetaminophen

Meperidine

ACTIVE COMPARATOR
Drug: Meperidine

Interventions

Paraceatmol 2Paracetamol 1
Meperidine

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists physical class I-II
  • term patients (≥ 37 weeks of gestation)

You may not qualify if:

  • previous cesarean section
  • hypertension, pre-eclampsia, eclampsia
  • intra-uterine growth retardation
  • intrauterine fetal death
  • morbid obesity (body mass index ≥ 35)
  • allergy to any of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz Medical City

Riyadh, Central, 11426, Saudi Arabia

Location

MeSH Terms

Conditions

Labor Pain

Interventions

AcetaminophenMeperidine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIsonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 14, 2011

Study Start

December 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 14, 2011

Record last verified: 2011-07

Locations