Clinical trial NCT02828176: The Effect of Left Uterine Displacement on Parturient Cardiovascular System
Official title: Hemodynamics Effects of Left Lateral Tilt on the Full Term Pregnant Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output
Keywords: cardiometry
uterine displacement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in cardiac output (L/min) before anesthesia
timeFrame: baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees
measure: change in cardiac output (L/min) after spinal anesthesia
timeFrame: baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees
Secondary outcomes:
measure: change in systemic vascular resistance (dyn.s/cm5)
timeFrame: 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
measure: change in mean arterial blood pressure (mmHg)
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References:
citation: HOWARD BK, GOODSON JH, MENGERT WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953 Apr;1(4):371-7. No abstract available.
citation: 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.
citation: 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.
citation: 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.