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Could the Cerebral Oximetry be a Good Technology to Measure Placental Oxygenation?

Could the Cerebral Oximetry (NIRS) be a Good Technology to Measure Placental Oxygenation in Pregnant Woman?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01834599
Enrollment
20
Registered
2013-04-18
Start date
2013-04-30
Completion date
2013-07-31
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placental Oxygenation

Keywords

placental oxygenation, obstetric anesthesia, NIRS, cerebral oximetry, cerebral oximeter

Brief summary

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

Detailed description

There is general agreement among experts to recommend the use of phenylephrine as first line therapy for the treatment of arterial hypotension induced by spinal anaesthesia during caesarean delivery. In some studies, there are trends toward a lower PaO2 values in the umbilical cord venous blood when the mother receive this vasopressor. These findings may be a result of the vasoconstrictor effect of phenylephrine on utero-placental vessels, and a subsequent increased oxygen extraction by the fetus. The possibility to extract more oxygen would provide a certain safety margin in the event of compromised utero-placental blood flow during normal pregnancy. However, this safety margin should not be taken for granted in cases where signs of fetal distress are present, and this situation might influence the choice of vasopressors. It is well establish on a physiological basis that during labour, utero-placental blood flow is lower during the contractions. This lower blood flow could result in a lower saturation value measured by the cerebral oximeter. Twenty patients in labour will be included in this study. Patients will be recruited in obstetric clinic during pregnancy. Based on the second trimester ultrasound, patients with anterior placenta will be included. During labour, once a functional epidural is in place, an Invos oximeter will be install. Two sensors will be applied on the abdomen (one above the placenta and the other above the myometrium at a place without placenta). Two sensors will also be applied on the extremities (forearm and leg).Saturation values and timing of the contractions will be recorded for sixty minutes. Half of the recording will be done with an oxygen mask. Vitals signs will also be registered every five minutes.

Interventions

tissue saturation measurement in pregnant women

Sponsors

Université de Montréal
CollaboratorOTHER
Maisonneuve-Rosemont Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Difference between Δp and Δm60 minutesΔp = 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)

Secondary

MeasureTime frameDescription
Difference of the area under the curve of saturation with and without oxygen60 minutesAp with Oxygen - Ap without oxygen; Am with oxygen - Am without oxygen

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026