Clinical trial NCT04083768: Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia
Official title: Effect of Different Left Lateral Table Tilt on Neonatal Acid-base Status and Maternal Hemodynamics for Elective Cesarean Delivery Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Cesarean Section
Spinal Anesthesia
Keywords: Position
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

Detailed description: When the pregnant woman in the third trimester is in the supine position, the enlarged uterus may oppress the inferior vena cava, thereby reducing the amount of blood and heart output of the pregnant woman. This affects the mother mainly, such as dizziness, nausea and vomiting, chills, and severe irritability，difficulty breathing or even cardiac arrest, the impact on the fetus is mainly the reduction of blood flow in the placenta, affecting the blood exchange of the uterus placenta, causing neonatal respiratory distress, acidosis and even death. The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy at term via elective cesarean section
* Height from 150 cm to 180 cm
* American Society of Anesthesiologists (ASA) grade from I to II grade
* BMI（Body Mass Index，mearsured weight divided by height squared）less than 35 kg/m2.

Exclusion Criteria:

* Transverse lie
* Fetal macrosomia
* Uterine abnormalities (e.g., large fibroids, bicornuate uterus)
* Polyhydramnios
* Ruptured membranes
* Oligohydramnios
* Intrauterine growth restriction
* Gestational or nongestational hypertension, diabetes, eclampsia
* Hypertensive disorder or any condition associated with autonomic neuropathy (e.g., diabetes mellitus for more than 10 yr), with renal failure
* Have contraindications for spinal anesthesia（Such as low back infection, spinal deformity, etc.）
* Participants refused to sign informed consent.

Primary outcomes:
measure: Umbilical artery blood pH
timeFrame: Immediately after delivery
Secondary outcomes:
measure: Other UA and UV blood gas analysis values（pH, base excess, lactate , Umbilical artery blood PaCO2
timeFrame: Immediately after delivery
measure: Fetal Apgar score (1 minute after birth) And 5 minutes
timeFrame: One minute and five minutes after the baby is delivered
measure: The incidence of nausea in pregnant women
timeFrame: Intraoperative
measure: The incidence of vomiting in pregnant women
timeFrame: Intraoperative
measure: The incidence of hypotension in pregnant women
timeFrame: Intraoperative
measure: The incidence of hypertension in pregnant women
timeFrame: Intraoperative
measure: The incidence of bradycardia in pregnant women
timeFrame: Intraoperative
measure: One min (T1), 3 min (T2), 5 min (T3), 7 min (T4), 9 min (T5), 11 min (T6), 13 min (T7) and 15 min (T8) blood pressure after subarachnoid injection (completion of the subarachnoid injection was defined as 0 time point)
timeFrame: Intraoperative
measure: One min (T1), 3 min (T2), 5 min (T3), 7 min (T4), 9 min (T5), 11 min (T6), 13 min (T7) and 15 min (T8) heart rate after subarachnoid injection (completion of the subarachnoid injection was defined as 0 time point)
timeFrame: Intraoperative
measure: Dosage of phenylephrine during surgery
timeFrame: Intraoperative
measure: Dosage of ephedrine during surgery
timeFrame: Intraoperative
measure: Dosage of atropine during surgery
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Liu Tian yu
state: Jiangsu
Study officials:
References:
citation: Fujita N, Higuchi H, Sakuma S, Takagi S, Latif MAHM, Ozaki M. Effect of Right-Lateral Versus Left-Lateral Tilt Position on Compression of the Inferior Vena Cava in Pregnant Women Determined by Magnetic Resonance Imaging. Anesth Analg. 2019 Jun;128(6):1217-1222. doi: 10.1213/ANE.0000000000004166.
citation: Shayegan B, Khorasani A, Knezevic NN. Left Lateral Table Tilt for Elective Cesarean Delivery under Spinal Anesthesia Should Not Be Abandoned. Anesthesiology. 2018 Apr;128(4):860-861. doi: 10.1097/ALN.0000000000002095. No abstract available.
citation: Abengochea A, Morales-Rosello J, Del Rio-Vellosillo M, Argente P, Barbera 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 Sep;123(3):733-4. doi: 10.1097/ALN.0000000000000791. No abstract available.
citation: Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. doi: 10.1093/bja/44.5.477. No abstract available.
citation: Liu T, Zou S, Guo L, Niu Z, Wang M, Xu C, Gao X, Shi Z, Guo X, Xiao H, Qi D. Effect of Different Positions During Surgical Preparation With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2021 Nov 1;133(5):1235-1243. doi: 10.1213/ANE.0000000000005320.