NCT02617823

Brief Summary

The purpose of this study is to determine if a lateral positioning of the pregnant woman after epidural analgesia increases the incidence of unilateral functioning epidurals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
950

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

November 24, 2015

Last Update Submit

September 30, 2019

Conditions

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • unilateral analgesic effect

    clinical judgement: mothers pain-sensation and cold sensation test

    evaluation of epidural effect after 30 min

Secondary Outcomes (2)

  • maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia

    evaluation of epidural effect after 30 min

  • fetal/neonatal safety measured with CTG and APGAR score

    CTG from start of study until birth, APGAR 2, 5 and 10min after birth

Study Arms (2)

semi-recumbent

NO INTERVENTION

rutine positioning at the hospital today

lateral position

EXPERIMENTAL

experimental position to be evaluated against rutine

Procedure: lateral position

Interventions

lateral positionPROCEDURE

patients placed on their left side after epidural catheter insertion

lateral position

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all adult pregnant women recieiving epidural analgesia

You may not qualify if:

  • participation refused
  • inability to understand study purpose/instructions
  • study postition could not be maintained for 30 min
  • ineffective epidural

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital SUS

Lund, Skåne County, 22185, Sweden

Location

University Hospital SUS

Malmo, Skåne County, 20502, Sweden

Location

Study Officials

  • Carolina Samuelsson, MD, PhD

    Region Skane, Head of the Department of Anesthesia and Intensive Care, University Hospital SUS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthetist

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 1, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)