NCT02827058

Brief Summary

The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

July 6, 2016

Last Update Submit

April 22, 2020

Conditions

Post-Dural Puncture Headache

Keywords

Delivery, obstetricAnalgesia, EpiduralInjections, EpiduralNeedlesCesarean Section

Outcome Measures

Primary Outcomes (1)

  • number of attempts until successful injection

    0 (injection time before delivery)

Secondary Outcomes (1)

  • incidence of post dural puncture headache

    48 hrs

Study Arms (2)

G25 pencil point needle

EXPERIMENTAL

healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle

Device: G25 pencil point needle

G27 pencil point needle

ACTIVE COMPARATOR

healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle

Device: G27 pencil point needle

Interventions

G25 pencil point needleDEVICE
G25 pencil point needle
G27 pencil point needleDEVICE
G27 pencil point needle

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • pregnant
  • spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)
  • informed consent

You may not qualify if:

  • chronic headache
  • (attempt to) epidural anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Østfold Hospital

Fredrikstad, Norway

Location

Unknown Facility

Fredrikstad, Norway

Location

Levanger Hospital

Levanger, Norway

Location

MeSH Terms

Conditions

Post-Dural Puncture HeadacheAgnosia

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Sverre Vamnes, md

    Østvold Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

NO(3)