Noninvasive Continuous Measurement of SpHb After Spontaneous Vaginal Delivery
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|ClinicalTrials.gov Identifier: NCT01505192|
Recruitment Status : Unknown
Verified January 2012 by Silvia Stirparo, Città di Roma Hospital.
Recruitment status was: Recruiting
First Posted : January 6, 2012
Last Update Posted : January 6, 2012
Aim of this study is to determine the physiological reference individual values (RI) of maternal continuous SpHb immediately after delivery in the post-partum period (continuous monitoring up to 2 hours after delivery) in order to establish the physiological Hb variations in response to the physiological blood loss due to delivery.
During labor all parturients will be tested for standard Laboratory Hb and monitored for at least 30 minutes with SpHb monitoring equipment (Radical-7™ Pulse CO-Oximeter and Rainbow DiSposable™ Adult Adhesive Sensor), and these values will be considered to be the baseline values.
Immediately after spontaneous vaginal delivery, venous blood sample will be taken for Hb determination and Radical 7 equipment for SpHb will be connected to the patient's finger and will be recorded for at least two hours after delivery. At the end of this period of observation a venous blood sample will be taken for Hb determination. Additional measurements of both SpHb and Lab Hb will be performed 24 hours after delivery.
|Condition or disease||Intervention/treatment||Phase|
|Delivery Uterine||Device: continuous Hb monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Determination of the Physiological Reference Values of Trend of Hemoglobin in the Post-partum Period After Spontaneous Vaginal Delivery. A Sequential Pilot Study Using the Noninvasive Continuous Technology of SpHb|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||May 2012|
- Device: continuous Hb monitor
Pre and post partum non invasive continuous Hb monitorOther Name: Masimo Radical 7
- SpHb monitoring equipment (Radical-7™ Pulse CO-Oximeter and Rainbow DiSposable™ Adult Adhesive Sensor, Masimo, Irvine, CA. Continuous Hemoglobin evaluation, measure unit: g/dL [ Time Frame: 24 hours postpartum ]To determine the physiological reference individual values (RI) of maternal continuous SpHb immediately after delivery in the post-partum period (continuous monitoring up to 2 hours after delivery) in order to establish the physiological Hb variations in response to the physiological blood loss due to delivery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505192
|Contact: Giorgio Capogna, MDfirstname.lastname@example.org|
|Città di Roma Hospital||Recruiting|
|Contact: Silvia Stirparo, MD email@example.com|
|Contact: Giorgio Capogna, MD firstname.lastname@example.org|
|Principal Investigator: Silvia Stirparo, MD|
|Principal Investigator: Giorgio Capogna, MD|
|Principal Investigator: Gabriele Tola, MD|
|Principal Investigator: Luca Ruggeri, MD|
|Principal Investigator:||Silvia Stirparo, MD||Città di Roma Hospital|
|Study Chair:||Giorgio Capogna, MD||Cittàdi Roma Hospital|