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NCT03409822 Clinical Trial

Non-invasive Hemoglobin Monitoring in Cesarean Section

Placenta Previa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03409822
Other study ID # Hb Csec
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2018
Est. completion date December 30, 2018

Study information
Verified date January 2019
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul National Univ. Bundang Hospital Seongnam Gyeonggi

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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Completed NCT03542552 - Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa Phase 3
Recruiting NCT03124472 - Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa N/A
Recruiting NCT03633175 - Progesterone in Patients With Placenta Previa Phase 2