Plethysmography Variability Index Monitoring for Parturients With Antepartum Hemorrhage

Antepartum Hemorrhage Clinical Trial

Official title:

Continuous Non Invasive Monitoring of Both Plethysmography Variability Index and Total Hemoglobin During Cesarean Section for Antepartum Hemorrhage As a Method For Early Detection of Bleeding

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02614053
• Other study ID #: mp3
• Status: Active, not recruiting
• Phase: N/A
• First received: November 23, 2015
• Last updated: November 25, 2015
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the use of continuous noninvasive intraoperative plethesmography variability index in conjunction with Hemoglobin levels monitoring using Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Anesthesiologist (ASA) Physical status I - II.

• patients aged from 18 to 40 years

• full-term multigravida parturients

• antepartum hemorrhage

• singleton fetus

Exclusion Criteria:

• Patients with known cardiac problem

• peripheral circulatory failure of the upper extremities

• significant liver disease

• significant renal disease

• significant coagulopathy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antepartum Hemorrhage
• Hemorrhage
• Obstetric Labor Complications
• Uterine Hemorrhage

Intervention

Device:
• Masimo Radical-7™ Pulse CO-Oximeter
a device collecting data regarding PVI, PI & spHB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pleth Variability Index		8 months	No
Secondary	hemoglobin level		8 months	No