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OpenTrials
Completed

NCT Number: NCT01834599

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cerebral oximetry

Device

tissue saturation measurement in pregnant women

Other names: NIRS, INVOS

Primary outcomes

  1. Difference between Δp and Δm

    Time frame: 60 minutes

    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)

Secondary outcomes

  1. Difference of the area under the curve of saturation with and without oxygen

    Time frame: 60 minutes

    Ap with Oxygen - Ap without oxygen; Am with oxygen - Am without oxygen

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Collaborators

  • Université de Montréal

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2013
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.