HypotensionNCT05427968
Comparison of Hypotension During Spinal Anaesthesia for C-section
An observational study of Hypotension and Cesarean Section, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypotension, Cesarean Section, Aortocaval Compression
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 1 Feb 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants after fulfilling the inclusion exclusion criteria were randomized by lottery method into two groups; supine group (Group 1) and left tilt group. (Group 2).
Who may be able to join
- Participants ≥ 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study.
Who cannot join
- Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index > 30 kg.m2), intrauterine growth were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi Medical University
Rawalpindi, Punjab Province, 46000
About this study
Official title: To Tilt or Not to Tilt?: Comparison of Severity of Hypotension Between Supine and Left Tilt Position During Spinal Anesthesia for Elective C-section
Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.
Read the detailed description
C-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. The choice lies with the mother. In spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. Hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (IVF) and aorta. This aortocaval compression (ACC) can also cause hypotension during C- section after spinal block.
The aim of our study was to study the effect of left tilt on systolic (SBP) and diastolic blood pressure (DBP), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.
- Conditions
- Hypotension, Cesarean Section, Aortocaval Compression
- Keywords
- Hypotension, Cesarean Section, Aortocaval Compression, Left titl
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Supine group | Spinal anaesthesia was administered in sitting position and then supine position was maintained. | |
| Left tilt group | Spinal anesthesia was administered in sitting position was then maintained on supine position until full anesthetic effect (motor and sensory loss) and then table was tilted 15 degrees to the left. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1 - Supine Group
Systolic blood pressures decreased significantly in the supine group
Measured: December 2021 to February 2022
Group 2 - Left tilt Group
The decrease in the diastolic blood pressure was marginally significant in the left tilt group.
Measured: December 2021 to February 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Dec 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubaid Azhar Dhillon, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427968
- Sponsor's protocol ID
- 2021-4711-17843
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Tilt or Not to Tilt?: Comparison of Severity of Hypotension Between Supine and Left Tilt Position During Spinal Anesthesia for Elective C-section
- ClinicalTrials.gov ID
- NCT05427968
- Acronym / sponsor ID
- 2021-4711-17843
- Conditions
- Hypotension, Cesarean Section, Aortocaval Compression
- Keywords
- Hypotension, Cesarean Section, Aortocaval Compression, Left titl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 22 Jun 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.
Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.
Detailed description
C-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. The choice lies with the mother. In spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. Hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (IVF) and aorta. This aortocaval compression (ACC) can also cause hypotension during C- section after spinal block.
The aim of our study was to study the effect of left tilt on systolic (SBP) and diastolic blood pressure (DBP), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine group | – | –Spinal anaesthesia was administered in sitting position and then supine position was maintained. |
| Left tilt group | – | –Spinal anesthesia was administered in sitting position was then maintained on supine position until full anesthetic effect (motor and sensory loss) and then table was tilted 15 degrees to the left. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants after fulfilling the inclusion exclusion criteria were randomized by lottery method into two groups; supine group (Group 1) and left tilt group. (Group 2).
Key inclusion criteria (1 listed)
- Participants ≥ 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study.
Key exclusion criteria (1 listed)
- Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index > 30 kg.m2), intrauterine growth were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Group 1 - Supine Group
Time frame: December 2021 to February 2022
Systolic blood pressures decreased significantly in the supine group
Group 2 - Left tilt Group
Time frame: December 2021 to February 2022
The decrease in the diastolic blood pressure was marginally significant in the left tilt group.
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 22 Jun 2022.
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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?
An observational study of Hypotension and Cesarean Section, run by Rawalpindi Medical College at 1 site in Pakistan.
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 1 inclusion and 1 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 22 Jun 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 Pakistan. 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?
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?
Group 1 - Supine Group (time frame: December 2021 to February 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2022.