Hypotensioncs positionNCT05595928
Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
An observational study of Hypotension, run by Aydin Maternity and Child Health Hospital at 1 site in Turkey (Türkiye).
Trial summary
After the approval of the Ethics Committee, 120 patients were planned to be included in the study between 15.06.2022 and 15.01.2023. Women who underwent elective cesarean delivery under spinal anesthesia were randomized to the supine position, 15° left-lateral tilt position, or 30° left-lateral tilt position. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- position
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 15 Jan 2023
- Phase
- Observational
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who underwent elective cesarean delivery under spinal anesthesia
Who may be able to join
- Elective cesarean delivery with term pregnancy
- Patient's height 150-180 cm
- American Society of Anesthesiologists (ASA) Physical Condition II
- Body Mass Index (BMI) <35 kg/m2.
Who cannot join
- Fetal macrosomia
- Uterine abnormalities (e.g. large fibroids, bicornuate uterus)
- Polyhydramnios
- Torn membranes, oligohydramnios
- Intrauterine growth restriction
- Gestational or non-gestational hypertension, diabetes, or eclampsia
- Contraindications for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Maternity and Child Health Hospital
Aydin
About this study
After the approval of the Ethics Committee, 120 patients were planned to be included in the study between 15.06.2022 and 15.01.2023. Women who underwent elective cesarean delivery under spinal anesthesia were randomized to the supine position, 15° left-lateral tilt position, or 30° left-lateral tilt position. The position will be changed to supine before the incision. It was planned to recruit 40 patients from each group, with a total of 120 patients. Anesthetic management was standardized and fluid administration with 10 mL/kg isotonic was planned. Hypotension (systolic blood pressure [SBP] reduction > 20% baseline or SBP <90 mm Hg) will be treated with intravenous bolus ephedrine based on maternal heart rate. The primary outcome is planned to include maternal SBP in 15 minutes of anesthesia induction, the amount of vasoactive drug administered before the end of surgery, and the incidence of hypotension during cesarean delivery.
Read the detailed description
Pregnant women in the supine position may compress the Inferior Vena Cava (IVC) by compression of the enlarged uterus in the third trimester. In this way, it is considered that it may reduce the amount of returning blood and cause hypotension. The incidence of this condition, called Supine Hypotension Syndrome, was reported to be 8%-10% (1-3). Spinal anesthesia, decreased sympathetic tonus, decreased systemic vascular resistance, and vasodilation may also cause hypotension in the patient (4).
It was considered that if the uterus is tilted, the pressure on the IVC would be removed, increasing the return, blood volume and cardiac output, improving the fetus, blood supply and oxygen supply (5). However, studies that were conducted so far have not proven significant differences and there is no routine standard practice (6-8). Here, the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree., References
- Howard BK, Goodson JH, Mengert WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953;1:371-377.
- Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994;83:774-788.
- Rees GA, Willis BA. Resuscitation in late pregnancy. Anaesthesia. 1988;43:347-349.
- Dyer RA, Reed AR, van Dyk D, et al. Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery. Anesthesiology. 2009;111:753-765.
- Kinsella SM. Lateral tilt for pregnant women: why 15-degree? Anaesthesia. 2003;58:835-836.
- Ellington C, Katz VL, Watson WJ, Spielman FJ. The effect of lateral tilt on maternal and fetal hemodynamic variables. Obstet Gynecol. 1991;77:201-203.
- Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003;97:256-258.
- Calvache JA, Mu.oz MF, Baron FJ. Hemodynamic effects of a right lumbar-pelvic wedge during spinal anesthesia for cesarean section. Int J Obstet Anesth. 2011;20:307-311.
- Conditions
- Hypotension
- Being tested
- position
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positionOther
To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.
| Study group | Role | What they receive |
|---|---|---|
| Supine | supine Receives: Other: position | |
| 15° left-lateral tilt position | 15° left-lateral tilt position. Receives: Other: position | |
| 30° left-lateral tilt position. | 30° left-lateral tilt position. Receives: Other: position |
What is being measured
The primary outcome is the main question the study is designed to answer.
position
the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start15 Jun 2022
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ferdi gülaştı, Aydin Maternity and Child Health Hospital
- Investigators
- FERDİ GÜLAŞTI, Principal investigator, Aydin Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595928
- Sponsor's protocol ID
- 2022-10
- Acronym
- cs position
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu 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 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05595928
- Acronym / sponsor ID
- cs position / 2022-10
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Aydin Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 27 Oct 2022 (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.
After the approval of the Ethics Committee, 120 patients were planned to be included in the study between 15.06.2022 and 15.01.2023. Women who underwent elective cesarean delivery under spinal anesthesia were randomized to the supine position, 15° left-lateral tilt position, or 30° left-lateral tilt position. The position will be changed to supine before the incision. It was planned to recruit 40 patients from each group, with a total of 120 patients. Anesthetic management was standardized and fluid administration with 10 mL/kg isotonic was planned. Hypotension (systolic blood pressure [SBP] reduction > 20% baseline or SBP <90 mm Hg) will be treated with intravenous bolus ephedrine based on maternal heart rate. The primary outcome is planned to include maternal SBP in 15 minutes of anesthesia induction, the amount of vasoactive drug administered before the end of surgery, and the incidence of hypotension during cesarean delivery.
Detailed description
Pregnant women in the supine position may compress the Inferior Vena Cava (IVC) by compression of the enlarged uterus in the third trimester. In this way, it is considered that it may reduce the amount of returning blood and cause hypotension. The incidence of this condition, called Supine Hypotension Syndrome, was reported to be 8%-10% (1-3). Spinal anesthesia, decreased sympathetic tonus, decreased systemic vascular resistance, and vasodilation may also cause hypotension in the patient (4).
It was considered that if the uterus is tilted, the pressure on the IVC would be removed, increasing the return, blood volume and cardiac output, improving the fetus, blood supply and oxygen supply (5). However, studies that were conducted so far have not proven significant differences and there is no routine standard practice (6-8). Here, the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree., References
- Howard BK, Goodson JH, Mengert WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953;1:371-377.
- Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994;83:774-788.
- Rees GA, Willis BA. Resuscitation in late pregnancy. Anaesthesia. 1988;43:347-349.
- Dyer RA, Reed AR, van Dyk D, et al. Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery. Anesthesiology. 2009;111:753-765.
- Kinsella SM. Lateral tilt for pregnant women: why 15-degree? Anaesthesia. 2003;58:835-836.
- Ellington C, Katz VL, Watson WJ, Spielman FJ. The effect of lateral tilt on maternal and fetal hemodynamic variables. Obstet Gynecol. 1991;77:201-203.
- Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003;97:256-258.
- Calvache JA, Mu.oz MF, Baron FJ. Hemodynamic effects of a right lumbar-pelvic wedge during spinal anesthesia for cesarean section. Int J Obstet Anesth. 2011;20:307-311.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supine | – | Other: positionsupine |
| 15° left-lateral tilt position | – | Other: position15° left-lateral tilt position. |
| 30° left-lateral tilt position. | – | Other: position30° left-lateral tilt position. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who underwent elective cesarean delivery under spinal anesthesia
Key inclusion criteria (4 listed)
- Elective cesarean delivery with term pregnancy
- Patient's height 150-180 cm
- American Society of Anesthesiologists (ASA) Physical Condition II
- Body Mass Index (BMI) <35 kg/m2.
Key exclusion criteria (7 listed)
- Fetal macrosomia
- Uterine abnormalities (e.g. large fibroids, bicornuate uterus)
- Polyhydramnios
- Torn membranes, oligohydramnios
- Intrauterine growth restriction
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 |
|---|---|---|
| positionTo compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt. | Other | 15° left-lateral tilt position, 30° left-lateral tilt position., Supine |
Primary outcome
position
Time frame: through study completion, an average of 6 months
the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Results publication: 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
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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.
FERDİ GÜLAŞTI principal investigator
Aydin Maternity and Child Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by Aydin Maternity and Child Health Hospital at 1 site in Turkey (Türkiye).
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 7 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. 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 Turkey (Türkiye). 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. 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?
Results are not available in the source record.
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?
position (time frame: through study completion, an average of 6 months). 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 NCT05595928, which also lists 1 linked publication.
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 27 Oct 2022.