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Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia

Effect of Different Left Lateral Table Tilt on Neonatal Acid-base Status and Maternal Hemodynamics for Elective Cesarean Delivery Under Spinal Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04083768
Enrollment
75
Registered
2019-09-10
Start date
2019-10-01
Completion date
2020-02-10
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Cesarean Section, Spinal Anesthesia

Keywords

Position

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.

Interventions

DEVICE15° and 30° wedge sponges

After the spinal anesthesia is completed, the wedge sponge is placed between the patient's pelvis and ribs and the wedge is removed before the skin is cut.

Sponsors

Xuzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Umbilical artery blood pHImmediately after deliveryUse a blood gas analyzer to measure

Secondary

MeasureTime frameDescription
Fetal Apgar score (1 minute after birth) And 5 minutesOne minute and five minutes after the baby is deliveredMeasured by Apgar score.The Apgar scoring system is divided into five categories(muscle tone,heart rate,grimace and respiration) Appearance. Each category receives a score of 0 to 2 points. At most, a child will receive an overall score of 10(The higher the score, the better the child's condition).
The incidence of nausea in pregnant womenIntraoperativeAnesthesiologist observes combined patient dictation.
The incidence of vomiting in pregnant womenIntraoperativeAnesthesiologist observes combined patient dictation
The incidence of hypotension in pregnant womenIntraoperativeThe increase of SBP \<20% baseline SBP or SBP \< 90/60mmHg
The incidence of hypertension in pregnant womenIntraoperativeThe increase of SBP \>20% baseline SBP
Other UA and UV blood gas analysis values(pH, base excess, lactate , Umbilical artery blood PaCO2Immediately after deliveryUse a blood gas analyzer to measure, PaCO2 in mmHg.
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)IntraoperativeMeasured by a sphygmomanometer.Systolic and diastolic blood pressure will be measured every minute during the study.
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)IntraoperativeObtained by ECG measurement
Dosage of phenylephrine during surgeryIntraoperativeUsed by an anesthesiologist based on the patient's blood pressure and heart rate.If the patient's blood pressure is less than 80% of the baseline level or less than 90/60 mmHg and the heart rate is greater than 60 times per minute, the patient is given 4 ug of phenylephrine.
Dosage of ephedrine during surgeryIntraoperativeUsed by an anesthesiologist based on the patient's blood pressure and heart rate.If the patient's blood pressure is less than 80% of the baseline level or less than 90/60 mmHg and the heart rate is smaller than 60 times per minute, the patient is given 6 mg of ephedrine.
Dosage of atropine during surgeryIntraoperativeUsed by an anesthesiologist based on the patient's blood pressure and heart rate.If the patient's heart rate is smaller than 60 times per minute, and blood pressure is more than 80% of the baseline level and more than 90/60 mmHg, the patient is given 0.5 mg of atropine.
The incidence of bradycardia in pregnant womenIntraoperativeHeart rate less than 60 times per minute

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026