Noninvasive Continuous Measurement of SpHb After Spontaneous Vaginal Delivery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Città di Roma Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Silvia Stirparo, Città di Roma Hospital
ClinicalTrials.gov Identifier:
NCT01505192
First received: December 28, 2011
Last updated: January 5, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by Città di Roma Hospital:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Device: continuous Hb monitor
    Pre and post partum non invasive continuous Hb monitor
    Other Name: Masimo Radical 7
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 September 30, 2014