NCT03127865

Brief Summary

The purpose of this study is to compare the sensitivity and the specificity of electrical cardiometry to the lung ultrasound in measuring thoracic lung water in pregnant females with pre-eclampsia. If electrical cardiometry is validated against ultrasound, it will be easy to use with numerical number that will not require advanced experience as with the ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 12, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

April 12, 2017

Last Update Submit

August 17, 2017

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • total thoracic fluid content

    total fluid content measured by electrical velocimetry device (cardiometry)

    after 30 minutes from patient admission to the obstetric casuality

Secondary Outcomes (6)

  • The need of diuretics

    during the period starting from admission till one day after delivery

  • extra-vascular lung water

    after 30 minutes from patient admission to the obstetric casuality

  • lung congestion

    during the period starting from admission till one day after delivery

  • serum albumin

    after 30 minutes from patient admission to the obstetric casuality

  • arterial blood pressure

    after 30 minutes from patient admission to the obstetric casuality

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pre-eclamptic patients scheduled for normal vaginal delivery or casearen section

You may qualify if:

  • pregnant
  • pre-eclamptic
  • In first stage of labor

You may not qualify if:

  • Eclampsia.
  • Second, third and fourth stages of labor on admission.
  • Patients with severe cardiac and/or pulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ahmed Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and critical care medicine

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 25, 2017

Study Start

April 18, 2017

Primary Completion

August 14, 2017

Study Completion

August 16, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)