Non-invasive Hemoglobin Monitoring in Cesarean Section
The Effectiveness of Intraoperative Non-invasive Hemoglobin Monitoring in Parturients With Placenta Previa Undergoing Cesarean Section: Prospective Observational Study
1 other identifier
interventional
39
1 country
1
Brief Summary
Non-invasive hemoglobin monitoring will be performed in patients who underwent cesarean section with placenta previa and this will be compared with actual laboratory findings. The investigators will investigate whether noninvasive hemoglobin monitoring can adequately reflect the massive bleeding that occurs within a short period of time and find out if it matches the actual laboratory findings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
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
First Submitted
Initial submission to the registry
January 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedJanuary 17, 2019
January 1, 2019
11 months
January 9, 2018
January 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The change of total hemoglobin
10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
Secondary Outcomes (5)
The change of oxygen content
10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
The change of methemoglobin
10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
The change of carboxyhemoglobin
10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
The change of pleth variability index
10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
The change of perfusion index
10 min before operation, 10 min after operation, 1 min after skin incision, 1 min after delivery of baby, 1 min after removal of placenta, 1 min after skin closure
Study Arms (1)
Placenta previa
OTHERInterventions
Attach the Masimo Rainbow SET® Radical-7 ™ pulse oximeter probe to the third or fourth finger and perform a Masimo SpHb ™ monitor.
Eligibility Criteria
You may qualify if:
- Pregnant woman
- Elective Cesarean section
- Placenta previa
You may not qualify if:
- Decline of consent
- Peripheral vascular disease
- Cyanosis due to congenital heart disease
- Refusal of transfusion
- Mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
January 9, 2018
First Posted
January 24, 2018
Study Start
February 5, 2018
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
January 17, 2019
Record last verified: 2019-01