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CompletedNCT03409822Updated Jan 17, 2019

Non-invasive Hemoglobin Monitoring in Cesarean Section

An interventional study of Masimo SpHb™ monitor in Placenta Previa, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-01-17.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
20 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Placenta Previa

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03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Pregnant woman
  • Elective Cesarean section
  • Placenta previa

Exclusion criteria

Exclusion Criteria:

  • Decline of consent
  • Peripheral vascular disease
  • Cyanosis due to congenital heart disease
  • Refusal of transfusion
  • Mental retardation
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Other
    Placenta previa

    Device: Masimo SpHb™ monitor

Interventions

  • DeviceMasimo SpHb™ monitor

    Attach the Masimo Rainbow SET® Radical-7 ™ pulse oximeter probe to the third or fourth finger and perform a Masimo SpHb ™ monitor.

05

What researchers measure

Primary outcomes

  1. 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

  1. The change of oxygen content

    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

  2. The change of methemoglobin

    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

  3. The change of carboxyhemoglobin

    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

  4. The change of pleth variability index

    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

  5. The change of perfusion index

    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

06

Study locations

1 site
  • Seoul National Univ. Bundang Hospital
    Seongnam, Gyeonggi 463-707, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03409822
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Hyo-Seok Na (Principle investigator, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jan 24, 2018
Start date
Feb 5, 2018
Primary completion
Dec 30, 2018
Completion
Dec 30, 2018
Last update
Jan 17, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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