The Effect of Left Uterine Displacement on Parturient Cardiovascular System

NCT ID: NCT02828176

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Cardiac Output

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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electric cardiometry

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 )

Intervention Type PROCEDURE

IV line insertion

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

Intervention Type PROCEDURE

spinal anesthesia ( subarachnoid block )

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.

Intervention Type PROCEDURE

electric cardiometry

after SAB the following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance at three different angles of left uterine lilt (0,15,30 degrees)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Hassab elnaby

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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HOWARD BK, GOODSON JH, MENGERT WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953 Apr;1(4):371-7. No abstract available.

Reference Type BACKGROUND
PMID: 13055188 (View on PubMed)

Higuchi H, Takagi S, Zhang K, Furui I, Ozaki M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Feb;122(2):286-93. doi: 10.1097/ALN.0000000000000553.

Reference Type BACKGROUND
PMID: 25603203 (View on PubMed)

Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD007623. doi: 10.1002/14651858.CD007623.pub3.

Reference Type BACKGROUND
PMID: 23543552 (View on PubMed)

Hasanin A, Soryal R, Kaddah T, Raouf SA, Abdelwahab Y, Elshafaei K, Elsayad M, Abdelhamid B, Fouad R, Mahmoud D, Hassabelnaby Y. Hemodynamic effects of lateral tilt before and after spinal anesthesia during cesarean delivery: an observational study. BMC Anesthesiol. 2018 Jan 15;18(1):8. doi: 10.1186/s12871-018-0473-0.

Reference Type DERIVED
PMID: 29334907 (View on PubMed)

Other Identifiers

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cardiometry

Identifier Type: -

Identifier Source: org_study_id

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