Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 15 Years and 55 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Criteria

Inclusion Criteria:

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

Study Design

Phase
Study Type
Observational
Observational Model
Ecologic or Community
Time Perspective
Retrospective

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Mark Norris, MD
Mark.Norris@bmc.org

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Lisa Leffert, MD
(203)785-4304
lisa.leffert@yale.edu

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.