Elective Cesarean SectionNCT04083768
Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia
A study testing 15° and 30° wedge sponges in people with Elective Cesarean Section and Spinal Anesthesia, run by Xuzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Elective Cesarean Section, Spinal Anesthesia
- What is being tested?
- 15° and 30° wedge sponges
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Transverse lie
- Fetal macrosomia
- Uterine abnormalities (e.g., large fibroids, bicornuate uterus)
- Polyhydramnios
- Ruptured membranes
- Oligohydramnios
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Left Lateral Table Tilt on Neonatal Acid-base Status and Maternal Hemodynamics 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.
Read the 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.
- Conditions
- Elective Cesarean Section, Spinal Anesthesia
- Being tested
- 15° and 30° wedge sponges
- Keywords
- Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15° and 30° wedge spongesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Supine group | Placebo comparator | After the patient completes the spinal anesthesia, the cesarean section is completed in the supine position. Receives: Device: 15° and 30° wedge sponges |
| 15° group | Active comparator | 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. Receives: Device: 15° and 30° wedge sponges |
| 30° group | Active comparator | 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. Receives: Device: 15° and 30° wedge sponges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical artery blood pH
Use a blood gas analyzer to measure
Measured: Immediately after delivery
Secondary outcomes (12)
Other UA and UV blood gas analysis values（pH, base excess, lactate , Umbilical artery blood PaCO2
Use a blood gas analyzer to measure, PaCO2 in mmHg.
Measured: Immediately after delivery
Fetal Apgar score (1 minute after birth) And 5 minutes
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）.
Measured: One minute and five minutes after the baby is delivered
The incidence of nausea in pregnant women
Anesthesiologist observes combined patient dictation.
Measured: Intraoperative
The incidence of vomiting in pregnant women
Anesthesiologist observes combined patient dictation
Measured: Intraoperative
The incidence of hypotension in pregnant women
The increase of SBP <20% baseline SBP or SBP < 90/60mmHg
Measured: Intraoperative
The incidence of hypertension in pregnant women
The increase of SBP >20% baseline SBP
Measured: Intraoperative
The incidence of bradycardia in pregnant women
Heart rate less than 60 times per minute
Measured: Intraoperative
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)
Measured by a sphygmomanometer.Systolic and diastolic blood pressure will be measured every minute during the study.
Measured: Intraoperative
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)
Obtained by ECG measurement
Measured: Intraoperative
Dosage of phenylephrine during surgery
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.
Measured: Intraoperative
Dosage of ephedrine during surgery
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.
Measured: Intraoperative
Dosage of atropine during surgery
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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Oct 2019
- Primary completion31 Jan 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Elective Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Xu, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083768
- Sponsor's protocol ID
- XYFY2019-KL126-02
- Status last verified
- Jun 2021
- First submitted
- 30 Aug 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available when this trial is finished and the article have been published
Publications
Fujita N, Higuchi H, Sakuma S, Takagi S, Latif MAHM, Ozaki M. Effect of Right-Lateral Versus Left-Lateral Tilt Position on Compression of the Inferior Vena Cava in Pregnant Women Determined by Magnetic Resonance Imaging. Anesth Analg. 2019 Jun;128(6):1217-1222. doi: 10.1213/ANE.0000000000004166.
PubMed 31094791Shayegan B, Khorasani A, Knezevic NN. Left Lateral Table Tilt for Elective Cesarean Delivery under Spinal Anesthesia Should Not Be Abandoned. Anesthesiology. 2018 Apr;128(4):860-861. doi: 10.1097/ALN.0000000000002095. No abstract available.
PubMed 29533301Abengochea A, Morales-Rosello J, Del Rio-Vellosillo M, Argente P, Barbera M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Sep;123(3):733-4. doi: 10.1097/ALN.0000000000000791. No abstract available.
PubMed 26284869Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. doi: 10.1093/bja/44.5.477. No abstract available.
PubMed 5044078Liu T, Zou S, Guo L, Niu Z, Wang M, Xu C, Gao X, Shi Z, Guo X, Xiao H, Qi D. Effect of Different Positions During Surgical Preparation With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2021 Nov 1;133(5):1235-1243. doi: 10.1213/ANE.0000000000005320.
PubMed 33350619
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Left Lateral Table Tilt on Neonatal Acid-base Status and Maternal Hemodynamics for Elective Cesarean Delivery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04083768
- Acronym / sponsor ID
- XYFY2019-KL126-02
- Conditions
- Elective Cesarean Section, Spinal Anesthesia
- Keywords
- Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supine group | Placebo comparator | Device: 15° and 30° wedge spongesAfter the patient completes the spinal anesthesia, the cesarean section is completed in the supine position. |
| 15° group | Active comparator | Device: 15° and 30° wedge spongesAfter 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. |
| 30° group | Active comparator | Device: 15° and 30° wedge spongesAfter 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Transverse lie
- Fetal macrosomia
- Uterine abnormalities (e.g., large fibroids, bicornuate uterus)
- Polyhydramnios
- Ruptured membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15° and 30° wedge spongesAfter 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. | Device | 15° group, 30° group, Supine group |
Primary outcome
Umbilical artery blood pH
Time frame: Immediately after delivery
Use a blood gas analyzer to measure
12 secondary outcomes
Other UA and UV blood gas analysis values（pH, base excess, lactate , Umbilical artery blood PaCO2
Time frame: Immediately after delivery
Fetal Apgar score (1 minute after birth) And 5 minutes
Time frame: One minute and five minutes after the baby is delivered
The incidence of nausea in pregnant women
Time frame: Intraoperative
The incidence of vomiting in pregnant women
Time frame: Intraoperative
The incidence of hypotension in pregnant women
Time frame: Intraoperative
The incidence of hypertension in pregnant women
Time frame: Intraoperative
The incidence of bradycardia in pregnant women
Time frame: Intraoperative
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
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
Dosage of phenylephrine during surgery
Time frame: Intraoperative
Dosage of ephedrine during surgery
Time frame: Intraoperative
Dosage of atropine during surgery
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Background: PubMed 31094791Fujita N, Higuchi H, Sakuma S, Takagi S, Latif MAHM, Ozaki M. Effect of Right-Lateral Versus Left-Lateral Tilt Position on Compression of the Inferior Vena Cava in Pregnant Women Determined by Magnetic Resonance Imaging. Anesth Analg. 2019 Jun;128(6):1217-1222. doi: 10.1213/ANE.0000000000004166.
- Background: PubMed 29533301Shayegan B, Khorasani A, Knezevic NN. Left Lateral Table Tilt for Elective Cesarean Delivery under Spinal Anesthesia Should Not Be Abandoned. Anesthesiology. 2018 Apr;128(4):860-861. doi: 10.1097/ALN.0000000000002095. No abstract available.
- Background: PubMed 26284869Abengochea A, Morales-Rosello J, Del Rio-Vellosillo M, Argente P, Barbera M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Sep;123(3):733-4. doi: 10.1097/ALN.0000000000000791. No abstract available.
- Results publication: PubMed 5044078Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. doi: 10.1093/bja/44.5.477. No abstract available.
- Derived from this study: PubMed 33350619Liu T, Zou S, Guo L, Niu Z, Wang M, Xu C, Gao X, Shi Z, Guo X, Xiao H, Qi D. Effect of Different Positions During Surgical Preparation With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2021 Nov 1;133(5):1235-1243. doi: 10.1213/ANE.0000000000005320.
- Individual participant dataSharing planned: No. IPD will be available when this trial is finished and the article have been published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15° and 30° wedge sponges in people with Elective Cesarean Section and Spinal Anesthesia, run by Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical artery blood pH (time frame: Immediately after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083768, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.