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

June 3, 2026 updated by: Yale University
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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • New Westminster, Canada
        • Recruiting
        • Royal Columbian Hospital & University of British Columbia
        • Contact:
        • Principal Investigator:
          • Barry Thorneloe, MD
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas
        • Contact:
        • Principal Investigator:
          • Nadir Sharawi
    • California
      • San Francisco, California, United States, 94158
      • Stanford, California, United States, 94303
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Brendan Carvalho, MD
    • Colorado
      • Arvada, Colorado, United States, 80007
        • Recruiting
        • University of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • Cristina Wood, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Adam Wendling, MD
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St Lukes Anesthesia Associates of Boise
        • Contact:
        • Principal Investigator:
          • Allen Botimer, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Principal Investigator:
          • Caroline Thomas, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Sapna Ravindranath, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Adeeb Oweidat, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Health System
        • Contact:
        • Principal Investigator:
          • Grace Shih, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland School of Medicine
        • Contact:
        • Principal Investigator:
          • Shobana Bharadwaj
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Phillip Hess
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Mark Norris, MD
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital
        • Contact:
        • Principal Investigator:
          • Sharon Reale, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Emily Sharpe, MD
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital St. Louis
        • Contact:
        • Principal Investigator:
          • Amber Benhardt
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico
        • Contact:
        • Principal Investigator:
          • Emily McQuaid-Hanson
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Lindsay Gennari, MD
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Greg Palleschi, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Nakiyah Knibbs
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Renaissance School of Medicine Stony Brook University
        • Contact:
        • Principal Investigator:
          • Tiffany Angelo, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • Laura Dean, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University o Cincinnati
        • Contact:
        • Principal Investigator:
          • Andrea Girnius, MD
      • Columbus, Ohio, United States, 43214
        • Completed
        • Ohio State University/Wexner Medical Center
    • Oregon
      • Portland, Oregon, United States, 97035
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Brandon Tagioka, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
          • Alexandra Nicholas, MD
          • Phone Number: 412-641-1778
        • Principal Investigator:
          • Alenandra Nicholas
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Katherine Hatter, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Holly Ende, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas-Houston
        • Contact:
        • Principal Investigator:
          • Barbara Orlando, MD
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Hofkamp
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Jessica Sheeran, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The subject population will reflect the diverse populations of the participating hospitals. The subject population will include pregnant women aged 15-55 years old who have a general anesthetic during their cesarean delivery. Non-English-speaking subjects will be included.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of General Anesthesia for Cesarean Delivery
Time Frame: Up to 5 years
The rates of general anesthesia for cesarean delivery among the institutions in the cohort will be assessed. Descriptive analyses of etiologies of and management of general anesthetics for cesarean delivery will also be performed.
Up to 5 years
Univariate Association Between Facility Type and the Rate of General Anesthesia for Cesarean Delivery
Time Frame: Up to 5 years
The association between facility type- non-academic affiliated private vs. academic affiliated private vs. military vs. academic (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.
Up to 5 years
Univariate Association Between SOAP Center of Excellence Designation and the Rate of General Anesthesia for Cesarean Delivery
Time Frame: Up to 5 years
The association between SOAP center of excellence designation- yes (reference) vs. no- with a difference in rates of general anesthesia for cesarean delivery will be assessed.
Up to 5 years
Univariate Association Between Maternal Level of Care and the Rate of General Anesthesia for Cesarean Association
Time Frame: Up to 5 years
The association between maternal level of care- I vs. II vs. III vs. IV (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.
Up to 5 years
Univariate Association Between Annual Live Births and the Rate of General Anesthesia for Cesarean Delivery
Time Frame: Up to 5 years
The association between increased numbers of annual live births (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.
Up to 5 years
Univariate Association Between Obstetric Anesthesiologist Coverage and the Rate of General Anesthesia for Cesarean Delivery
Time Frame: Up to 5 years
The association between increased rates of labor and delivery floor coverage by obstetric anesthesiologists (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.
Up to 5 years
Univariate Association Between Institutional Policies for Labor Epidural Management and the Rate of General Anesthesia for Cesarean Delivery
Time Frame: Up to 5 years
The association between the presence of institutional policies for labor epidural management- yes (reference) vs. no- and a difference in rates of general anesthesia for cesarean delivery will be assessed.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery
Time Frame: Up to 5 years
Among the cohort of general anesthetics for cesarean delivery, the incidence of difficult intubation will be determined.
Up to 5 years
Univariate Association Between Mallampati Score and the Risk of Difficult Intubation
Time Frame: Up to 5 years
The association between increased Mallampati score- I or II (reference) vs. III vs. IV- and a difference in risk of difficult intubation will be assessed.
Up to 5 years
Univariate Association Between Neck Mobility and the Risk of Difficult Intubation
Time Frame: Up to 5 years
The association between neck mobility- full (reference) vs. limited vs. poor and a difference in risk of difficult intubation will be assessed.
Up to 5 years
Univariate Association Between Neck Circumference and the Risk of Difficult Intubation
Time Frame: Up to 5 years
The association between neck circumference- thin or average (reference) vs. thick and a difference in risk of difficult intubation will be assessed.
Up to 5 years
Univariate Association Between Neck Length and the Risk of Difficult Intubation
Time Frame: Up to 5 years
The association between neck length- long or average (reference) vs. short and a difference in risk of difficult intubation will be assessed.
Up to 5 years
Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation
Time Frame: Up to 5 years
The association between thyromental distance- >6.5cm (reference) vs. 3.5-6.5cm vs. <3.5cm and a difference in risk of difficult intubation will be assessed.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Lisa Leffert, MD, Yale Univesrity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2000033638

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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