The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry

Last updated: January 2, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia

Labor/delivery

Treatment

N/A

Clinical Study ID

NCT06030063
2000033638
  • Ages 15-55
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Study Design

Total Participants: 5000
Study Start date:
February 22, 2024
Estimated Completion Date:
September 30, 2029

Study 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).

Connect with a study center

  • Royal Columbian Hospital & University of British Columbia

    New Westminster,
    Canada

    Active - Recruiting

  • University of Arkansas

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94303
    United States

    Active - Recruiting

  • University of Colorado Hospital

    Arvada, Colorado 80007
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • St Lukes Anesthesia Associates of Boise

    Boise, Idaho 83712
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Health System

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mercy Hospital St. Louis

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • University of New Mexico

    Albuquerque, New Mexico 87106
    United States

    Active - Recruiting

  • Albany Medical Center

    Albany, New York 12208
    United States

    Active - Recruiting

  • Northwell Health

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Renaissance School of Medicine Stony Brook University

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • University o Cincinnati

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Ohio State University/Wexner Medical Center

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97035
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • University of Texas-Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Baylor Scott & White Medical Center

    Temple, Texas 76508
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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