Indication for Care or Intervention Related to Labor or Delivery With Baby DeliveredDADBNCT02193542
Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients
An observational study of Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant woman presenting for vaginal or cesarean delivery
Who may be able to join
- Pregnant woman presenting for vaginal or cesarean delivery
Who cannot join
- Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or emergent delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Anthony Chau, MD, 617-732-5500, achau2@partners.org
Lawrence Tsen, MD
About this study
Official title: Prospective Observation Study of Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.
Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.
Read more
If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.
The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.
Read the detailed description
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.
Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.
If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.
The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.
- Keywords
- regional anesthesia, general anesthesia, obstetric
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 |
|---|---|---|
| Pregnant patient | Pregnant woman presenting for vaginal or cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of difficult regional and general anesthesia
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start1 Jul 2014
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Indication for Care or Intervention Related to Labor or Delivery With Baby DeliveredStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Ching Tsen, Brigham and Women's Hospital
- Investigators
- Lawrence C Tsen, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193542
- Sponsor's protocol ID
- bwhobanes-DADB
- Acronym
- DADB
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2014
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available.
PubMed 16129992Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097/00003081-200309000-00020. No abstract available.
PubMed 12972749Ross BK. ASA closed claims in obstetrics: lessons learned. Anesthesiol Clin North Am. 2003 Mar;21(1):183-97. doi: 10.1016/s0889-8537(02)00051-2.
PubMed 12698840Ellinas EH, Eastwood DC, Patel SN, Maitra-D'Cruze AM, Ebert TJ. The effect of obesity on neuraxial technique difficulty in pregnant patients: a prospective, observational study. Anesth Analg. 2009 Oct;109(4):1225-31. doi: 10.1213/ANE.0b013e3181b5a1d2.
PubMed 19762752Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
PubMed 19420004
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation Study of Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients
- ClinicalTrials.gov ID
- NCT02193542
- Acronym / sponsor ID
- DADB / bwhobanes-DADB
- Keywords
- regional anesthesia, general anesthesia, obstetric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Jul 2014 (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.
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.
Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.
If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.
The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.
Detailed description
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.
Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.
If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.
The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant patient | – | –Pregnant woman presenting for vaginal or cesarean delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant woman presenting for vaginal or cesarean delivery
Key inclusion criteria (1 listed)
- Pregnant woman presenting for vaginal or cesarean delivery
Key exclusion criteria (1 listed)
- Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or emergent delivery
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
incidence of difficult regional and general anesthesia
Time frame: within 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 16129992Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available.
- Background: PubMed 12972749Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097/00003081-200309000-00020. No abstract available.
- Background: PubMed 12698840Ross BK. ASA closed claims in obstetrics: lessons learned. Anesthesiol Clin North Am. 2003 Mar;21(1):183-97. doi: 10.1016/s0889-8537(02)00051-2.
- Background: PubMed 19762752Ellinas EH, Eastwood DC, Patel SN, Maitra-D'Cruze AM, Ebert TJ. The effect of obesity on neuraxial technique difficulty in pregnant patients: a prospective, observational study. Anesth Analg. 2009 Oct;109(4):1225-31. doi: 10.1213/ANE.0b013e3181b5a1d2.
- Background: PubMed 19420004Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
- Individual participant dataSharing planned: No
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.
Lawrence C Tsen, MD principal investigator
Brigham and Women's Hospital
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 Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered, run by Brigham and Women's Hospital at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of difficult regional and general anesthesia (time frame: within 30 days). 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 NCT02193542, which also lists 5 linked publications.
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 13 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.