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

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ClinicalTrials.gov Identifier: NCT04083768
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chao Xu, Xuzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Elective Cesarean Section Spinal Anesthesia Device: 15° and 30° wedge sponges Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Different Left Lateral Table Tilt on Neonatal Acid-base Status and Maternal Hemodynamics for Elective Cesarean Delivery Under Spinal Anesthesia
Estimated Study Start Date : December 30, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Placebo Comparator: Supine group
After the patient completes the spinal anesthesia, the cesarean section is completed in the supine position.
Device: 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.

Active Comparator: 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.
Device: 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.

Active Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. Umbilical artery blood pH [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure


Secondary Outcome Measures :
  1. Umbilical artery blood base excess [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure, base excess in mmol/L

  2. Umbilical artery blood lactate [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure,lactate in mmol/L.

  3. Umbilical artery blood PaO2 [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure, PaO2 in mmHg.

  4. 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.

  5. Umbilical vein blood pH [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure.

  6. Umbilical vein blood base excess [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure, base excess in mmol/L.

  7. Umbilical vein blood lactate. [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure,lactate in mmol/L.

  8. Umbilical vein blood PaO2. [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure, PaO2 in mmHg.

  9. Umbilical vein blood PaCO2. [ Time Frame: Immediately after delivery ]
    Use a blood gas analyzer to measure, PaCO2 in mmHg.

  10. 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).

  11. The incidence of nausea in pregnant women [ Time Frame: Intraoperative ]
    Anesthesiologist observes combined patient dictation.

  12. The incidence of vomiting in pregnant women [ Time Frame: Intraoperative ]
    Anesthesiologist observes combined patient dictation

  13. The incidence of hypotension in pregnant women [ Time Frame: Intraoperative ]
    The increase of SBP <20% baseline SBP or SBP < 90/60mmHg

  14. The incidence of hypertension in pregnant women [ Time Frame: Intraoperative ]
    The increase of SBP >20% baseline SBP

  15. The incidence of bradycardia in pregnant women [ Time Frame: Intraoperative ]
    Heart rate less than 60 times per minute

  16. 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.

  17. 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

  18. 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.

  19. Time interval from the completion of combined spinal and epidural anesthesia to the first use of phenylephrine [ Time Frame: Intraoperative ]
    Timing by timepiece

  20. The time interval from the injection of the subarachnoid space to the delivery of the fetus [ Time Frame: Intraoperative ]
    Timing by timepiece

  21. Skin incision to fetal delivery interval [ Time Frame: Intraoperative ]
    Timing by timepiece

  22. Dosage of epidural bupivacaine during surgery [ Time Frame: Intraoperative ]
    Use according to the patient's analgesic needs.If the patient complains of pain (VAS is greater than or equal to three points) or the obstetrician says that the abdominal muscles are tense and the surgery cannot be performed, the patient is given epidural lidocaine 0.1g.

  23. 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.

  24. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083768


Contacts
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Contact: Qi Dunyi, M.D. 86-15162159886 qdy6808@163.com

Locations
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China, Jiangsu
Liu Tian yu Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Liu Tian yu, M.D.    86-13952156318    260354344@qq.com   
Sponsors and Collaborators
Xuzhou Medical University
Publications of Results:
Other Publications:
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Responsible Party: Chao Xu, Principal Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT04083768    
Other Study ID Numbers: XYFY2019-KL126-02
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be available when this trial is finished and the article have been published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chao Xu, Xuzhou Medical University:
Position