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NCT Number: NCT04083768

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

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.

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Key information

Conditions

Elective Cesarean Section Spinal Anesthesia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Liu Tian yu

Xuzhou, Jiangsu, 221000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

15° and 30° wedge sponges

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.

Primary outcomes

  1. Umbilical artery blood pH

    Time frame: Immediately after delivery

    Use a blood gas analyzer to measure

Secondary outcomes

  1. Other UA and UV blood gas analysis values（pH, base excess, lactate , Umbilical artery blood PaCO2

    Time frame: Immediately after delivery

    Use a blood gas analyzer to measure, PaCO2 in mmHg.

  2. Fetal Apgar score (1 minute after birth) And 5 minutes

    Time frame: One minute and five minutes after the baby is delivered

    Measured 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）.

  3. The incidence of nausea in pregnant women

    Time frame: Intraoperative

    Anesthesiologist observes combined patient dictation.

  4. The incidence of vomiting in pregnant women

    Time frame: Intraoperative

    Anesthesiologist observes combined patient dictation

  5. The incidence of hypotension in pregnant women

    Time frame: Intraoperative

    The increase of SBP <20% baseline SBP or SBP < 90/60mmHg

  6. The incidence of hypertension in pregnant women

    Time frame: Intraoperative

    The increase of SBP >20% baseline SBP

  7. The incidence of bradycardia in pregnant women

    Time frame: Intraoperative

    Heart rate less than 60 times per minute

  8. 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)

    Time frame: Intraoperative

    Measured by a sphygmomanometer.Systolic and diastolic blood pressure will be measured every minute during the study.

  9. 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)

    Time frame: Intraoperative

    Obtained by ECG measurement

  10. Dosage of phenylephrine during surgery

    Time frame: Intraoperative

    Used 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.

  11. Dosage of ephedrine during surgery

    Time frame: Intraoperative

    Used 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.

  12. Dosage of atropine during surgery

    Time frame: Intraoperative

    Used 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.

Sponsors and collaborators

Lead sponsor

Xuzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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