Caesarean SectionNCT01278238
Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia
A study testing Phenylephrine and Lower limb compression in people with Caesarean Section, run by Anestesiavdelingen Baerum Sykehus at 1 site in Norway.
Trial summary
The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section
- What is being tested?
- Phenylephrine and Lower limb compression
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Oct 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm
Who cannot join
- Any form of disease or anomalities:
- Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effect of Prophylactic Phenylephrine Versus Lower Limb Compression in Women During Caesarean Section Under Spinal Anaesthesia
The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.
The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.
- Conditions
- Caesarean Section
- Being tested
- Phenylephrine, Lower limb compression, Placebo
- Keywords
- Hypotension, Caesarean section, Spinal anaesthesia, Lower limb compression / wrapping, Phenylephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min
Lower limb compressionDevice
Tight bandaging of lower extremity up to hips with compression bandages
PlaceboOther
Neither phenylephrine nor lower limb bandaging
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Active comparator | Not described Receives: Drug: Phenylephrine |
| Lower limb compression | Active comparator | Not described Receives: Device: Lower limb compression |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive arterial bloodpressure
Measured: Until end of operation, up to roughly 1 hour
Secondary outcomes (4)
pH value from umbilical vessels of the newborn
Measured: straight after delivery
APGAR score of the newborn
Measured: 1 + 5 + 10 minutes after delivery
Need for rescue pressor (ephedrine, phenylephrine)
Measured: Until end of operation, roughly 1 hour
Cardiac Output
Measured: Until end of operation, roughly 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anestesiavdelingen Baerum Sykehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jana Christine Kuhn, Anestesiavdelingen Baerum Sykehus
- Investigators
- Jana Christine Kuhn, Dr.med., Principal investigator, Bærum sykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278238
- Sponsor's protocol ID
- 2009-013025-42
- Other IDs
- 2009
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2011
- Last updated
- 11 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effect of Prophylactic Phenylephrine Versus Lower Limb Compression in Women During Caesarean Section Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT01278238
- Acronym / sponsor ID
- 2009-013025-42
- Conditions
- Caesarean Section
- Keywords
- Hypotension, Caesarean section, Spinal anaesthesia, Lower limb compression / wrapping, Phenylephrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Anestesiavdelingen Baerum SykehusUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Jan 2011 (estimated)
- 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 purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.
The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Active comparator | Drug: Phenylephrine |
| Lower limb compression | Active comparator | Device: Lower limb compression |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm
Key exclusion criteria (2 listed)
- Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster
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 |
|---|---|---|
| PhenylephrineIntravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min | Drug | Phenylephrine |
| Lower limb compressionTight bandaging of lower extremity up to hips with compression bandages | Device | Lower limb compression |
| PlaceboNeither phenylephrine nor lower limb bandaging | Other | Placebo |
Primary outcome
Invasive arterial bloodpressure
Time frame: Until end of operation, up to roughly 1 hour
4 secondary outcomes
pH value from umbilical vessels of the newborn
Time frame: straight after delivery
APGAR score of the newborn
Time frame: 1 + 5 + 10 minutes after delivery
Need for rescue pressor (ephedrine, phenylephrine)
Time frame: Until end of operation, roughly 1 hour
Cardiac Output
Time frame: Until end of operation, roughly 1 hour
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 11 Jan 2013.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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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.
Jana Christine Kuhn, Dr.med. principal investigator
Bærum sykehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine and Lower limb compression in people with Caesarean Section, run by Anestesiavdelingen Baerum Sykehus at 1 site in Norway.
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 2 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 11 Jan 2013. 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 Norway. 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?
Invasive arterial bloodpressure (time frame: Until end of operation, up to roughly 1 hour). 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 11 Jan 2013.