NCT02523755

Brief Summary

With an efficient epidural analgesia the physiological effects of pain are disabled during labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after labor with and without epidural analgesia. With more efficient breathing, the occurence of atelectasis should be reduced; this effect will be investigated in these settings for the first time with the electrical impedance tomography, which is a completely non-invasive measure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 pregnancy

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4 pregnancy

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

July 28, 2015

Last Update Submit

December 5, 2016

Conditions

PregnancyAtelectasis

Keywords

epidural analgesia for laborrespiratory functionelectrical impedance tomography

Outcome Measures

Primary Outcomes (1)

  • Better lung function after labor with epidural analgesia

    Using EIT we will map the degree of atelectasis

    24h

Study Arms (2)

Epidural analgesia Ropivacaine

ACTIVE COMPARATOR

Placement of an epidural catheter to achieve pain relief

Drug: Epidural analgesia RopivacaineDrug: Absence of epidural analgesia

Absence of epidural analgesia

SHAM COMPARATOR

No placement of an epidural catheter either because of patient refusal or contraindication

Drug: Epidural analgesia RopivacaineDrug: Absence of epidural analgesia

Interventions

Epidural analgesia RopivacaineDRUG

Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics

Absence of epidural analgesiaEpidural analgesia Ropivacaine
Absence of epidural analgesiaDRUG

Measurement of regional distribution as assessed by EIT before and after delivery

Absence of epidural analgesiaEpidural analgesia Ropivacaine

Eligibility Criteria

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

You may qualify if:

  • ASA I
  • ASA II

You may not qualify if:

  • Caesarian
  • \< 18 years
  • Expulsions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Pulmonary AtelectasisRespiratory Aspiration

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maxim Doutreluigne, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Laszlo L Szegedi, Prof.

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Data Nurse

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 14, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)