Cesarean Section ComplicationsPhase 4NCT03182114
Supine Versus Left Lateral Tilted Position During Cesarean Delivery
A Phase 4 study testing supine position, left lateral tilted position and Bupivacaine in people with Cesarean Section Complications, run by Cairo University at 1 site in Egypt.
Trial summary
In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- supine position, left lateral tilted position and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2017to 20 Jan 2019
- Phase
- Phase 4
- 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
- full term
- singleton pregnant women
- scheduled for elective cesarean delivery
Who cannot join
- Cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- baseline systolic blood pressure (SBP) < 100 mmHg
- body mass index > 35
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
ahmed Hasanin, Lecturer, +2010095076954, ahmedmohamedhasanin@gmail.com
About this study
Official title: Hemodynamic Effects of Supine Position Versus Left Lateral Tilted Position During Cesarean Delivery: a Randomized Controlled Trial.
In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position
Read the detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.
- Conditions
- Cesarean Section Complications
- Being tested
- supine position, left lateral tilted position, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supine positionOther
the patient will be placed in regular supine position after spinal anesthesia
left lateral tilted positionOther
the patient will be placed in left lateral tilted position after spinal anesthesia
BupivacaineDrug
Also called Marcaine
The patient will receive 10 mg Bupivacaine for spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| supine position | Placebo comparator | the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position Receives: Other: supine position; Drug: Bupivacaine |
| Left lateral tilted position | Experimental | the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position Receives: Other: left lateral tilted position; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postspinal hypotension
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
Measured: 30 minutes after spinal anesthesia
Secondary outcomes (10)
severe postspinal hypotension
The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
Measured: 30 minutes after spinal anesthesia
Post-delivery hypotension
number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion
Measured: 10 minutes after delivery
systolic blood pressure
systolic blood pressure measured in mmHg
Measured: 60 minutes after spinal block
diastolic blood pressure
diastolic blood pressure measured in mmHg
Measured: 60 minutes after spinal block
heart rate
heart rate measured in beats per minute
Measured: 60 minutes after spinal block
incidence of nausea and vomiting
number of patients who develop nausea and vomiting divided by the total number of patients in the group
Measured: 60 minutes after spinal block
ephedrine consumption
total amount of ephedrine consumed during the operation (measured in milligrams)
Measured: 60 minutes after spinal block
Atropine consumption
total amount of atropine consumed during the operation (measured in milligrams
Measured: 60 minutes after spinal block
APGAR score
APGAR score for detection of the well being of the fetus
Measured: 1 minute after delivery
APGAR score
APGAR score for detection of the well being of the fetus
Measured: 10 minute after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start12 Jun 2017
- Primary completion15 Jan 2019 (estimated)
- Study completion20 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Professor, Study chair, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182114
- Sponsor's protocol ID
- N-52-2017
- Status last verified
- Jul 2018
- First submitted
- 7 Jun 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Supine Position Versus Left Lateral Tilted Position During Cesarean Delivery: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03182114
- Acronym / sponsor ID
- N-52-2017
- Conditions
- Cesarean Section Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- 20 Jan 2019 (estimated)
- First posted
- 9 Jun 2017 (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.
In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position
Detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine position | Placebo comparator | Other: supine position, Drug: Bupivacainethe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position |
| Left lateral tilted position | Experimental | Other: left lateral tilted position, Drug: Bupivacainethe patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full term
- singleton pregnant women
- scheduled for elective cesarean delivery
Key exclusion criteria (5 listed)
- Cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- baseline systolic blood pressure (SBP) < 100 mmHg
- body mass index > 35
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 |
|---|---|---|
| supine positionthe patient will be placed in regular supine position after spinal anesthesia | Other | supine position |
| left lateral tilted positionthe patient will be placed in left lateral tilted position after spinal anesthesia | Other | Left lateral tilted position |
| BupivacaineAlso: MarcaineThe patient will receive 10 mg Bupivacaine for spinal anesthesia | Drug | Left lateral tilted position, supine position |
Primary outcome
postspinal hypotension
Time frame: 30 minutes after spinal anesthesia
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
10 secondary outcomes
severe postspinal hypotension
Time frame: 30 minutes after spinal anesthesia
Post-delivery hypotension
Time frame: 10 minutes after delivery
systolic blood pressure
Time frame: 60 minutes after spinal block
diastolic blood pressure
Time frame: 60 minutes after spinal block
heart rate
Time frame: 60 minutes after spinal block
incidence of nausea and vomiting
Time frame: 60 minutes after spinal block
ephedrine consumption
Time frame: 60 minutes after spinal block
Atropine consumption
Time frame: 60 minutes after spinal block
APGAR score
Time frame: 1 minute after delivery
APGAR score
Time frame: 10 minute after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
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.
Ahmed Mukhtar, Professor study chair
Head of research committee section in anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing supine position, left lateral tilted position and Bupivacaine in people with Cesarean Section Complications, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 5 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 9 Jul 2018. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ahmed Shash, Professor (+201001033999, shashahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postspinal hypotension (time frame: 30 minutes after spinal anesthesia). 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 9 Jul 2018.