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

Xuzhou Medical University

Status: Completed

Conditions: Spinal Anesthesia; Elective Cesarean Section

Treatments: Device: 15° and 30° wedge sponges

Study type: Interventional

Funder types: Other

Identifiers

NCT04083768

XYFY2019-KL126-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups, including a placebo group

Supine group

Placebo Comparator group

Description:

After the patient completes the spinal anesthesia, the cesarean section is completed in the supine position.

Treatment:

Device: 15° and 30° wedge sponges

15° group

Active Comparator group

Description:

After the patient completed the spinal anesthesia, the preoperative preparation (about 10 minutes) was completed with a left tilt of 15°, and the cesarean section was completed using the supine position after the skin was cut.

Treatment:

Device: 15° and 30° wedge sponges

30° group

Active Comparator group

Description:

After the patient completed the spinal anesthesia, the preoperative preparation (about 10 minutes) was completed with a left tilt of 30°, and the cesarean section was completed using the supine position after the skin was cut.

Treatment:

Device: 15° and 30° wedge sponges