Obstetric Anesthesia CareOBAAMA-INTNCT02380586
Obstetric Anaesthesia And Analgesia Month Attributes - International
An observational study of Obstetric Anesthesia Care, run by Brno University Hospital at 1 site in Czechia.
Trial summary
A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic and Slovak Republic. Read more about this study
- Who is it for?
- Ages 16 to 70 years, women only
- Conditions the study is for
- Obstetric Anesthesia Care
- What is being tested?
- Obstetric anesthesia and analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 3,040 participants
- Where
- 1 siteCzechia
- Study dates
- Nov 2015to Dec 2015
- 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 16 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women in labor
Who may be able to join
- Women in labor undergoing anesthesia care
Who cannot join
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National Survey on Obstetric Anesthesia and Analgesia Care - International
A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic and Slovak Republic.
Read the detailed description
A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic.
Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.
- Conditions
- Obstetric Anesthesia Care
- Being tested
- Obstetric anesthesia and analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric anesthesia and analgesiaProcedure or surgery
All anesthesia procedures during labor: labor analgesia, anesthesia for Cesarean section, anesthesia for procedures in third stage of labor
| Study group | Role | What they receive |
|---|---|---|
| Women in labor undergoing anesthesia care | Women in labor undergoing anesthesia care Receives: Procedure: Obstetric anesthesia and analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
A national survey of current practice of obstetric anesthesia and analgesia in Czech Republic and Slovak Republic
Monitoring of all obstetric anesthesia procedures in peripartal period and anesthesia complications: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.
Measured: Parturition period, up to 24 hours after labor
Secondary outcomes (1)
Types of anesthesia a analgesia in peripartal period
To describe current practice a complications related to peripartal anesthesia care
Measured: Parturition period, up to 24 hours after labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Anesthesia CareStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 3,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, Masaryk University, General University Hospital, Prague, Czech society of anesthesiology, resuscitation a intensive care - ČLS JEP
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, MD, Ph.D, Study chair, FN Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380586
- Sponsor's protocol ID
- MU_IBA1026
- Acronym
- OBAAMA-INT
- Status last verified
- Jul 2016
- First submitted
- 28 Feb 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harazim H, Stourac P, Blaha J, Grochova M, Klozova R, Noskova P, Seidlova D, Richterova S, Svoboda M, Jarkovsky J, Silova X, Jezova B, Steinbach J, Zemanek M, Mannova J, Slavik J, Novakova Z, Misakova L, Firment J. The influence of mode of anaesthesia for caesarean delivery on neonatal Apgar scores in the Czech Republic and Slovakia: secondary analysis of the results of an international survey in 2015. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Jun;163(2):147-154. doi: 10.5507/bp.2019.008. Epub 2019 Apr 9.
PubMed 30976125
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Survey on Obstetric Anesthesia and Analgesia Care - International
- ClinicalTrials.gov ID
- NCT02380586
- Acronym / sponsor ID
- OBAAMA-INT / MU_IBA1026
- Conditions
- Obstetric Anesthesia Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,040 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, Masaryk University, General University Hospital, Prague, Czech society of anesthesiology, resuscitation a intensive care - ČLS JEP
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Mar 2015 (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.
A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic and Slovak Republic.
Detailed description
A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic.
Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women in labor undergoing anesthesia care | – | Procedure: Obstetric anesthesia and analgesiaWomen in labor undergoing anesthesia care |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women in labor
Key inclusion criteria (1 listed)
- Women in labor undergoing anesthesia care
Key exclusion criteria (1 listed)
- not meeting inclusion criteria
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 |
|---|---|---|
| Obstetric anesthesia and analgesiaAll anesthesia procedures during labor: labor analgesia, anesthesia for Cesarean section, anesthesia for procedures in third stage of labor | Procedure or surgery | Women in labor undergoing anesthesia care |
Primary outcome
A national survey of current practice of obstetric anesthesia and analgesia in Czech Republic and Slovak Republic
Time frame: Parturition period, up to 24 hours after labor
Monitoring of all obstetric anesthesia procedures in peripartal period and anesthesia complications: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.
1 secondary outcome
Types of anesthesia a analgesia in peripartal period
Time frame: Parturition period, up to 24 hours after labor
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 Jul 2016.
- Derived from this study: PubMed 30976125Harazim H, Stourac P, Blaha J, Grochova M, Klozova R, Noskova P, Seidlova D, Richterova S, Svoboda M, Jarkovsky J, Silova X, Jezova B, Steinbach J, Zemanek M, Mannova J, Slavik J, Novakova Z, Misakova L, Firment J. The influence of mode of anaesthesia for caesarean delivery on neonatal Apgar scores in the Czech Republic and Slovakia: secondary analysis of the results of an international survey in 2015. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Jun;163(2):147-154. doi: 10.5507/bp.2019.008. Epub 2019 Apr 9.
Related trials for Obstetric Anesthesia Care
RecruitingObservational study
Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients
Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered
RecruitingObservational study
Non-invasive Detection of Iron Deficiency in Obstetrics
Iron Deficiency Anemia of Pregnancy, Iron-deficiency
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.
Petr Štourač, MD, Ph.D study chair
FN Brno
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 Obstetric Anesthesia Care, run by Brno University Hospital at 1 site in Czechia.
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 Jul 2016. 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 Czechia. 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?
A national survey of current practice of obstetric anesthesia and analgesia in Czech Republic and Slovak Republic (time frame: Parturition period, up to 24 hours after labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380586, which also lists 1 linked publication.
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 Jul 2016.