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

NCT06030063 | Recruiting

• 1 other identifier: 2000033638
• Study Type: observational
• Target: 5,000
• Locations: 2 countries
• Sites: 35

Brief 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.

Conditions

Cesarean Delivery; General Anesthesia

Outcome Measures

Primary Outcomes (7)

• Rates of General Anesthesia for Cesarean Delivery

  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

  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

  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

  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

  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

  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

  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 Outcomes (6)

• Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery

  Up to 5 years

• Univariate Association Between Mallampati Score and the Risk of Difficult Intubation

  Up to 5 years

• Univariate Association Between Neck Mobility and the Risk of Difficult Intubation

  Up to 5 years

• Univariate Association Between Neck Circumference and the Risk of Difficult Intubation

  Up to 5 years

• Univariate Association Between Neck Length and the Risk of Difficult Intubation

  Up to 5 years

Eligibility Criteria

• Age: 15 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (35)

University of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Stanford University

Stanford, California, 94303, United States

RECRUITING

University of Colorado Hospital

Arvada, Colorado, 80007, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

St Lukes Anesthesia Associates of Boise

Boise, Idaho, 83712, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Health System

Kansas City, Kansas, 66160, United States

RECRUITING

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87106, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Renaissance School of Medicine Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University o Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Ohio State University/Wexner Medical Center

Columbus, Ohio, 43214, United States

COMPLETED

Oregon Health & Science University

Portland, Oregon, 97035, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas-Houston

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White Medical Center

Temple, Texas, 76508, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Royal Columbian Hospital & University of British Columbia

New Westminster, Canada

RECRUITING

Study Officials

• Lisa Leffert, MD

  Yale Univesrity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Leffert, MD

CONTACT

(203)785-4304; lisa.leffert@yale.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 8, 2023
• Study Start: February 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

US (34); CA (1)