PregnancyNCT01438099
Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients
An observational study of Pregnancy, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Jul 2013
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: all women after thirty weeks of pregnancy, experiencing spontaneous or induced labor
Who may be able to join
- all women who request epidural analgesia for labor
Who cannot join
- all women who present contraindication for epidural analgesia
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Varese, Varese, 21100
About this study
This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.
Read the detailed description
This study has four specific aims:
- to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space;
- to compare between ultrasound evaluation and needle measure of skin-epidural space depth;
- to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients;
- to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.
- Conditions
- Pregnancy
- Keywords
- epidural analgesia, ultrasound, labor analgesia, labor
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 |
|---|---|---|
| normal subjects | parturients admitted to the labor ward who request epidural analgesia with BMI < 30 | |
| obese subjects | parturients admitted to the labor ward who request epidural analgesia with BMI > 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The congruity between palpatory technique and ultrasound lumbar evaluation
The congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space performing epidural analgesia
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (1)
Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients
Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients will be measured and compared to the needle depth
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Severgnini, Università degli Studi dell'Insubria
- Investigators
- Paolo Severgnini, Prof., Principal investigator, Universita' degli Studi dell'Insubria, Varese, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438099
- Sponsor's protocol ID
- 18894
- Status last verified
- Aug 2013
- First submitted
- 14 Sep 2011
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients
- ClinicalTrials.gov ID
- NCT01438099
- Acronym / sponsor ID
- 18894
- Conditions
- Pregnancy
- Keywords
- epidural analgesia, ultrasound, labor analgesia, labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Sep 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.
This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.
Detailed description
This study has four specific aims:
- to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space;
- to compare between ultrasound evaluation and needle measure of skin-epidural space depth;
- to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients;
- to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal subjects | – | –parturients admitted to the labor ward who request epidural analgesia with BMI < 30 |
| obese subjects | – | –parturients admitted to the labor ward who request epidural analgesia with BMI > 30 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all women after thirty weeks of pregnancy, experiencing spontaneous or induced labor
Key inclusion criteria (1 listed)
- all women who request epidural analgesia for labor
Key exclusion criteria (1 listed)
- all women who present contraindication for epidural analgesia
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
The congruity between palpatory technique and ultrasound lumbar evaluation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
The congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space performing epidural analgesia
1 secondary outcome
Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
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 26 Aug 2013.
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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.
Paolo Severgnini, Prof. principal investigator
Universita' degli Studi dell'Insubria, Varese, Italy
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 Pregnancy, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 26 Aug 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 Italy. 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 congruity between palpatory technique and ultrasound lumbar evaluation (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days). 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 26 Aug 2013.