NCT01834599

Brief Summary

To assess the potential of the cerebral oximeter to measure placental oxygenation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

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

Study Start

First participant enrolled

April 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

April 15, 2013

Last Update Submit

April 14, 2016

Conditions

Placental Oxygenation

Keywords

placental oxygenationobstetric anesthesiaNIRScerebral oximetrycerebral oximeter

Outcome Measures

Primary Outcomes (1)

  • Difference between Δp and Δm

    Δp = Difference between the mean value area under the curve for the placenta and arm = (Ap- Af) Δm= Difference between the mean value area under the curve for the myometrium and arm = (Am- Af)

    60 minutes

Secondary Outcomes (1)

  • Difference of the area under the curve of saturation with and without oxygen

    60 minutes

Study Arms (1)

anterior placenta

Cerebral oximetry device used to obtain: Saturation value of the placenta probe with no oxygen, saturation value of the placenta probe with oxygen, saturation value of the myometrium probe with no oxygen saturation value of the myometrium probe with oxygen saturation value of the forearm probe with no oxygen, saturation value of the forearm probe with oxygen saturation value of the leg probe with no oxygen saturation value of the leg probe with oxygen Timing between the contractions measure by cardiotocography

Device: cerebral oximetry

Interventions

cerebral oximetryDEVICE

tissue saturation measurement in pregnant women

Also known as: NIRS, INVOS
anterior placenta

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy pregnant woman at term gestation in labour

You may qualify if:

  • healthy pregnant woman (ASA I or II)
  • Term gestation ( \> 37 weeks)
  • Normal pregnancy
  • vaginal delivery
  • obstetrical epidural in place
  • anterior placenta

You may not qualify if:

  • patient refusal
  • Any contraindication to neuraxial anesthesia
  • cesarean section
  • multiple gestation
  • placentation abnormalities
  • anormal placental perfusion
  • Placental Abruption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Study Officials

  • Christian Loubert, MD, FRCPC

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christian Loubert, MD, FRCPC

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

CA(1)