Non-invasive Hemoglobin Monitoring in Cesarean Section

January 15, 2019 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Placenta previa
Attach the Masimo Rainbow SET® Radical-7 ™ pulse oximeter probe to the third or fourth finger and perform a Masimo SpHb ™ monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 5, 2018

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (ACTUAL)

January 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Hb Csec

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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