Summary

Eligibility
for females ages 15-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Won Lee, MD

Description

Summary

The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery.

Details

This is a central repository with data from 25-40 participating SOAP institutions/hospitals.

The primary and secondary aims of this study are as follows:

  1. To determine the institutional factors associated with rates of general anesthesia for cesarean delivery
  2. To perform a descriptive analysis of characteristics of general anesthesia for cesarean delivery cases
  3. To determine maternal and anesthetic predictors of difficult intubation

Data will be collected from each participating SOAP institution. Institutional data will include information on the characteristics of the institution such as maternal level of care, numbers of lives birth, staffing models, etc. This data will be collected prior to subjects being enrolled into the registry and again at the registry closure to look at intuitional changes over time.

Inclusion into the registry is based on the following criteria:

  1. Pregnant women who have had a general anesthetic for Cesarean delivery
  2. 15-55 years old

The general anesthesia registry will collect data on subject demographics in a deidentified manner, including characteristics of the birth and delivery, gestational age, maternal morbidities, and anesthetic management.

The granular detail requested in the registry database will help to better understand the nuances of how and why decisions are made about proceeding with general anesthesia in these cases, and once done, how to implement this clinical course. As not all of these data points are routinely recorded in the medical record, optimal data capture requires the treating anesthesiologist to complete the registry entry as soon as possible after conclusion of patient care.

Data will be collected for approximately 5 years and maintained indefinitely. Data is entered into a Yale REDCap registry and will not contain subject identifiers. An estimated 5000 subjects will be enrolled into the data repository. This is based on a published report of 45 institutions' data investigating a subtopic of this question (15 years yielding 15,000 general anesthetics).

Keywords

Cesarean Delivery, General Anesthesia

Eligibility

For females ages 15-55

Inclusion Criteria:

-Pregnant women aged 15-55 who have had a general anesthetic for Cesarean delivery

Locations

  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Stanford University accepting new patients
    Stanford California 94303 United States

Lead Scientist at UCSF

  • Won Lee, MD
    Assistant Professor, Anesthesia, School of Medicine. Authored (or co-authored) 5 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
ID
NCT06030063
Study Type
Observational
Participants
Expecting 5000 study participants
Last Updated