Noninvasive Continuous Measurement of SpHb After Spontaneous Vaginal Delivery
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Purpose
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 | Intervention |
|---|---|
|
Delivery Uterine |
Device: continuous Hb monitor |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
-
Device: continuous Hb monitor
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Healthy parturients in labor
Exclusion Criteria:
- Parturient with coagulation defects, or with anticoagulant therapy
Contacts and Locations| Contact: Giorgio Capogna, MD | capogna.giorgio@gmail.com |
| Italy | |
| Città di Roma Hospital | Recruiting |
| Roma, Italy | |
| Contact: Silvia Stirparo, MD silvia.s@tin.it | |
| Contact: Giorgio Capogna, MD capogna.giorgio@gmail.com | |
| 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 |
More Information
No publications provided
| Responsible Party: | Silvia Stirparo, Staff Anesthesiologist, Città di Roma Hospital |
| ClinicalTrials.gov Identifier: | NCT01505192 History of Changes |
| Other Study ID Numbers: | Postpartum non invasive Hb |
| Study First Received: | December 28, 2011 |
| Last Updated: | January 5, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Città di Roma Hospital:
|
Those in Labor, Delivery and the Puerperium |
ClinicalTrials.gov processed this record on May 16, 2013