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Clinical Trials/NCT03409822
NCT03409822
Completed
N/A

The Effectiveness of Intraoperative Non-invasive Hemoglobin Monitoring in Parturients With Placenta Previa Undergoing Cesarean Section: Prospective Observational Study

Seoul National University Bundang Hospital1 site in 1 country39 target enrollmentFebruary 5, 2018
ConditionsPlacenta Previa

Overview

Phase
N/A
Intervention
Not specified
Conditions
Placenta Previa
Sponsor
Seoul National University Bundang Hospital
Enrollment
39
Locations
1
Primary Endpoint
The change of total hemoglobin
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2018
End Date
December 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyo-Seok Na

Principle investigator

Seoul National University Bundang Hospital

Eligibility Criteria

Inclusion Criteria

  • Pregnant woman
  • Elective Cesarean section
  • Placenta previa

Exclusion Criteria

  • Decline of consent
  • Peripheral vascular disease
  • Cyanosis due to congenital heart disease
  • Refusal of transfusion
  • Mental retardation

Outcomes

Primary Outcomes

The change of total hemoglobin

Time Frame: 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

  • 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 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)
  • 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)

Study Sites (1)

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