Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT02193542

Conditions

Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief 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 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.

Conditions

Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered

Study ID

NCT02193542

Start date

Jul 1, 2014

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant woman presenting for vaginal or cesarean delivery

Exclusion Criteria:

  • Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or emergent delivery

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant patient

Pregnant woman presenting for vaginal or cesarean delivery

Primary outcome measure

  • incidence of difficult regional and general anesthesia [ Time Frame: within 30 days ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Lawrence Tsen, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • regional anesthesia
  • general anesthesia
  • obstetric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-13.