Skip to main content
OpenTrials
Completed

NCT Number: NCT02828176

The Effect of Left Uterine Displacement on Parturient Cardiovascular System

The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

At operating room, patients will be monitored using non invasive blood, ECG, pulse oximeter and electrical cardiometry. Baseline readings will be taken in supine position then repeated after putting the patient in left lateral position with angle 15 then 30 degrees.

Then two IV lines will be inserted and 500cc crystalloid will be administered. Subarachnoid block will be performed in sitting position under complete aseptic conditions using 25 g spinal needle. Subarachnoid block will be achieved by injecting 10 mg hyperbaric bupivacaine plus 25 ug fentanyl. The block will be considered successful if adequate block reached T4 dermatome.

After successful block the hemodynamic variables will be recorded in the same positions as before (0,15, 30 degrees left uterine tilt).

A minimum number of 61 patients was calculated to have a study power of 80% and alpha error of 0.05.

SPSS Chicago 18 software will be used for data analysis. Categorical data will be presented as frequencies, continuous variables will presented as mean ± standard deviation and will be analyzed using on way analysis of variance (ANOVA) with post-hoc pairwise comparisons using bonferroni test. A P value of 0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • full term, singleton, American society of anesthesiologists (ASA) I and II pregnant women scheduled for cs

Exclusion criteria

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

Treatment and study plan

electric cardiometry

Procedure

The following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance.

these parameters are measured on arrival to operating room before subarachnoid block in three different angles of lateral uterine tilt ( 0, 15 and 30 degrees )

IV line insertion

Procedure

two Iv lines are inserted and 500cc crystalloid is administered to parturient .

spinal anesthesia ( subarachnoid block )

Procedure

Subarachnoid block (SAB) was performed in sitting position under complete asepsis using 25 g spinal needle. SAB was achieved by intrathecal injection of 10 mg hyperbaric bupivacaine plus 25ug fentanyl. Success of SAB was tested within five minutes after drug injection. SAB was considered successful if adequate block reached T4 dermatome.

Primary outcomes

  1. change in cardiac output (L/min) before anesthesia

    Time frame: baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees

    measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).

  2. change in cardiac output (L/min) after spinal anesthesia

    Time frame: baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees

    measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).

Secondary outcomes

  1. change in systemic vascular resistance (dyn.s/cm5)

    Time frame: baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block

  2. change in mean arterial blood pressure (mmHg)

    Time frame: baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block

    measured by oscillometry in mmHg

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Hemodynamics Effects of Left Lateral Tilt on the Full Term Pregnant Females

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.