NCT03181776

Brief Summary

The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 17, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

June 22, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

April 17, 2017

Last Update Submit

July 5, 2018

Conditions

Cesarean Section ComplicationsSpinal Anesthetic Complications

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    Cardiac output in liters per minute measured by electrical cardiometry

    30 minutes after spinal anesthesia in different angles of left lateral tilting

Secondary Outcomes (9)

  • cardiac output

    before spinal anesthesia in different angles of left lateral tilting

  • mean arterial blood pressure

    before spinal anesthesia in different angles of left lateral tilting

  • mean arterial blood pressure

    30 minutes after spinal anesthesia in different angles of left lateral tilting

  • stroke volume

    before spinal anesthesia in different angles of left lateral tilting

  • stroke volume

    30 minutes after spinal anesthesia in different angles of left lateral tilting

  • +4 more secondary outcomes

Study Arms (1)

left lateral tilting arm

EXPERIMENTAL

all patients will be put in three angles of left lateral tilt in randomized order (supine position - left lateral tilting in 15 degrees - and left lateral tilting in 30 degrees) and the hemodynamic data will be compared in the three angles.

Other: left lateral tilting in 15 degreesOther: left lateral tilting in 30 degreesOther: supine position

Interventions

left lateral tilting in 15 degreesOTHER

The mother will be placed in left lateral tilted position (15 degrees) using a standard wedge

left lateral tilting arm
left lateral tilting in 30 degreesOTHER

The mother will be placed in left lateral tilted position (30 degrees) using a standard wedge

left lateral tilting arm
supine positionOTHER

The mother will be placed in standard supine position

left lateral tilting arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • full term parturients scheduled for cesarean delivery

You may not qualify if:

  • BMI \> 35 Kg/m2, polyhydramnios, history of impaired cardiac contractility, valvular heart disease, cardiac arrhythmias, hypertensive pregnancy disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ahmed Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Central Study Contacts

Ahmed Shash, Professor

CONTACT

+201001033999shashahmed@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The study will investigate the effect of different tilting angles on the hemodynamics of full term pregnants before and after spinal anesthesia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and critical care medicine

Study Record Dates

First Submitted

April 17, 2017

First Posted

June 9, 2017

Study Start

June 22, 2017

Primary Completion

November 25, 2018

Study Completion

December 5, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)