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

Placental Oxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834599
• Other study ID #: LoubertHMR2013/04
• Status: Completed
• Phase: N/A
• First received: April 15, 2013
• Last updated: April 14, 2016
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: April 2016
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Placental Oxygenation

Intervention

Device:
• cerebral oximetry
tissue saturation measurement in pregnant women

Locations

Country	Name	City	State
Canada	Maisonneuve Rosemont Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between ?p and ?m	?p = Difference between the mean value area under the curve for the placenta and arm = (Ap- Af) ?m= Difference between the mean value area under the curve for the myometrium and arm = (Am- Af)	60 minutes	No
Secondary	Difference of the area under the curve of saturation with and without oxygen	Ap with Oxygen - Ap without oxygen; Am with oxygen - Am without oxygen	60 minutes	No