HypotensionNCT01891175
Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities
A study testing Elective caesarean section under spinal anaesthesia. in people with Hypotension, run by Parc de Salut Mar at 3 sites in Spain.
Trial summary
The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- What is being tested?
- Elective caesarean section under spinal anaesthesia.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- May 2013to Sep 2014
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed.
Who cannot join
- Caesarean section urgent / emergent
- Caesarean section with epidural anaesthesia
- Caesarean section of multiple pregnancies
- Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (<32 weeks)
- Valvular heart disease and / or ischemic
- High blood pressure diagnosed and in treatment.
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- Sepsis
- Morbid obesity (BMI> 40)
- Insulin-dependent diabetes
- Block level achieved with spinal anaesthesia> T5
- Patients that can not meet the study protocol
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Vall d'Hebron Hospital
Barcelona, Barcelona, 08035
About this study
Official title: Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.
The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby.
The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.
- Conditions
- Hypotension
- Being tested
- Elective caesarean section under spinal anaesthesia.
- Keywords
- Caesarean, hypotension, Spinal Anaesthesia, intermittent pneumatic compression, lower extremities
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective caesarean section under spinal anaesthesia.Procedure or surgery
Patients with scheduled caesarean.
Elective caesarean section under spinal anaesthesia.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intermittent pneumatic compression | Experimental | With intermittent pneumatic compression of the lower extremities (Covidien / Kendall SCD ™ sequential compression systems) plus phenylephrine perfusion (usual treatment)in elective caesarean section under spinal anaesthesia. Receives: Procedure: Elective caesarean section under spinal anaesthesia. |
| Only pheniyephrine perfussion | Active comparator | No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia. Receives: Procedure: Elective caesarean section under spinal anaesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of needed vasopressor (phenylephrine).
Measured: From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.
Secondary outcomes (1)
Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).
Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.
Measured: From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionSep 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lourdes Trillo, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891175
- Sponsor's protocol ID
- CAESAREANFENI
- Status last verified
- Feb 2016
- First submitted
- 24 May 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.
- ClinicalTrials.gov ID
- NCT01891175
- Acronym / sponsor ID
- CAESAREANFENI
- Conditions
- Hypotension
- Keywords
- Caesarean, hypotension, Spinal Anaesthesia, intermittent pneumatic compression, lower extremities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Jul 2013 (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 hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby.
The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent pneumatic compression | Experimental | Procedure: Elective caesarean section under spinal anaesthesia.With intermittent pneumatic compression of the lower extremities (Covidien / Kendall SCD ™ sequential compression systems) plus phenylephrine perfusion (usual treatment)in elective caesarean section under spinal anaesthesia. |
| Only pheniyephrine perfussion | Active comparator | Procedure: Elective caesarean section under spinal anaesthesia.No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed.
Key exclusion criteria (11 listed)
- Caesarean section urgent / emergent
- Caesarean section with epidural anaesthesia
- Caesarean section of multiple pregnancies
- Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (<32 weeks)
- Valvular heart disease and / or ischemic
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 |
|---|---|---|
| Elective caesarean section under spinal anaesthesia.Patients with scheduled caesarean. | Procedure or surgery | Intermittent pneumatic compression |
| Elective caesarean section under spinal anaesthesia. | Procedure or surgery | Only pheniyephrine perfussion |
Primary outcome
The dose of needed vasopressor (phenylephrine).
Time frame: From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.
1 secondary outcome
Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).
Time frame: From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).
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 23 Feb 2016.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective caesarean section under spinal anaesthesia. in people with Hypotension, run by Parc de Salut Mar at 3 sites in Spain.
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 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
The dose of needed vasopressor (phenylephrine). (time frame: From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.). 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 23 Feb 2016.