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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-02-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

NCT02883075

Pregnancy Anesthesia

COMPLETED NA

Hemodynamic Effect of Left Tilting in Cesarean Delivery

NCT03181776

Cesarean Section Complications Spinal Anesthetic Complications

UNKNOWN NA

An Evaluation of Maternal Position During Cesarean Delivery

NCT02872181

Cesarean Section

UNKNOWN NA

Neonatal Acid-Base Status After C Section With Maternal Tilt vs. Supine

NCT02243423

Aortocaval Compression Fetal Acidosis

COMPLETED NA

Effect of Position During Spinal Anesthesia on Hemodynamic Change in Cesarean Section

NCT02253381

Hypotension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elective Cesarean Section Spinal Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supine group

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

Group Type PLACEBO_COMPARATOR

15° and 30° wedge sponges

Intervention Type DEVICE

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.

15° group

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.

Group Type ACTIVE_COMPARATOR

15° and 30° wedge sponges

Intervention Type DEVICE

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.

30° group

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.

Group Type ACTIVE_COMPARATOR

15° and 30° wedge sponges

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

15° 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No