NCT03105830

Brief Summary

Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor. Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug in blood

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Status
unknown

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

First Submitted

Initial submission to the registry

February 6, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

February 6, 2017

Last Update Submit

April 7, 2017

Conditions

Labour

Outcome Measures

Primary Outcomes (1)

  • pain score

    vas

    pain assessmant by vas scale during the latent phase of labor at delivery room. the data will be presented through study completion, an average of 1 year

Secondary Outcomes (4)

  • level of paracetamol

    at the end of labor , blood samples from the mother and from the umbelical cord. the data will be presented through study completion, an average of 1 year

  • pain experience

    72 hours after labor , the data will be presented through study completion, an average of 1 year

  • pain influences

    72 hours after labor, the data will be presented through study completion, an average of 1 year

  • pain experience and analgesia

    72 hours after labor, the data will be presented through study completion, an average of 1 year

Study Arms (1)

intervention and data collection

EXPERIMENTAL

pain management by iv paracetamol

Drug: iv paracetamol

Interventions

iv paracetamolDRUG

iv paracetamol

Also known as: perfalgan
intervention and data collection

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details18+
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • latent phase of labour
  • low risk

You may not qualify if:

  • high risk
  • allergy to paracetamol
  • liver insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of delivery room

Study Record Dates

First Submitted

February 6, 2017

First Posted

April 10, 2017

Study Start

May 1, 2017

Primary Completion

April 20, 2018

Study Completion

June 1, 2018

Last Updated

April 10, 2017

Record last verified: 2017-04