Noninvasive Continuous Measurement of SpHb After Spontaneous Vaginal Delivery
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
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 28, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJanuary 6, 2012
January 1, 2012
3 months
December 28, 2011
January 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SpHb monitoring equipment (Radical-7™ Pulse CO-Oximeter and Rainbow DiSposable™ Adult Adhesive Sensor, Masimo, Irvine, CA. Continuous Hemoglobin evaluation, measure unit: g/dL
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.
24 hours postpartum
Interventions
Pre and post partum non invasive continuous Hb monitor
Eligibility Criteria
You may qualify if:
- Healthy parturients in labor
You may not qualify if:
- Parturient with coagulation defects, or with anticoagulant therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Città di Roma Hospital
Roma, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Stirparo, MD
Città di Roma Hospital
- STUDY CHAIR
Giorgio Capogna, MD
Cittàdi Roma Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Anesthesiologist
Study Record Dates
First Submitted
December 28, 2011
First Posted
January 6, 2012
Study Start
December 1, 2011
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
January 6, 2012
Record last verified: 2012-01