NCT02614053

Brief 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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

November 23, 2015

Last Update Submit

November 25, 2015

Conditions

Antepartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Pleth Variability Index

    8 months

Secondary Outcomes (1)

  • hemoglobin level

    8 months

Interventions

Masimo Radical-7™ Pulse CO-OximeterDEVICE

a device collecting data regarding PVI, PI \& spHB

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

parturients with antepartum hemorrhage admitted for cesarean section

You may qualify if:

  • Anesthesiologist (ASA) Physical status I - II.
  • patients aged from 18 to 40 years
  • full-term multigravida parturients
  • antepartum hemorrhage
  • singleton fetus

You may not qualify if:

  • Patients with known cardiac problem
  • peripheral circulatory failure of the upper extremities
  • significant liver disease
  • significant renal disease
  • significant coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • nadia yo helmy, md

    professor of anaesthesia cairo university

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia faculty of medicine cairo university

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 25, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11