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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
Sponsor:
Information provided by (Responsible Party):
Silvia Stirparo, Città di Roma Hospital

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.


Condition or disease Intervention/treatment Phase
Delivery Uterine Device: continuous Hb monitor Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : December 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care


Intervention Details:
  • Device: continuous Hb monitor
    Pre and post partum non invasive continuous Hb monitor
    Other Name: Masimo Radical 7


Primary Outcome Measures :
  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 [ 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy parturients in labor

Exclusion Criteria:

  • Parturient with coagulation defects, or with anticoagulant therapy

Information from the National Library of Medicine

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


Contacts
Contact: Giorgio Capogna, MD capogna.giorgio@gmail.com

Locations
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         
Sponsors and Collaborators
Città di Roma Hospital
Investigators
Principal Investigator: Silvia Stirparo, MD Città di Roma Hospital
Study Chair: Giorgio Capogna, MD Cittàdi Roma Hospital

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
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Keywords provided by Silvia Stirparo, Città di Roma Hospital:
Those in Labor, Delivery and the Puerperium