Plethysmography Variability Index Monitoring for Parturients With Antepartum Hemorrhage

November 25, 2015 updated by: ahmed elsakka, Kasr El Aini Hospital

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

124

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

parturients with antepartum hemorrhage admitted for cesarean section

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pleth Variability Index
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
hemoglobin level
Time Frame: 8 months
8 months

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Study Director: nadia yo helmy, md, professor of anaesthesia cairo university

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

March 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Estimate)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mp3

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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