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Cesarean DeliveryNCT06030063

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

An observational study of Cesarean Delivery and General Anesthesia, run by Yale University at 35 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 15 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Delivery, General Anesthesia
How many people
5,000 participants
Where
35 sitesin 2 countries
Study dates
22 Feb 2024to Dec 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

35 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Lisa Leffert, MD contact

(203)785-4304

lisa.leffert@yale.edu

35 sites in 2 countries

United States34 sites, 33 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Mantab Sheikh, sheikhm@amc.edu

    Lindsay Gennari, MD

    Recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87106

    Emily McQuaid-Hanson, MD, emcquaidhanson@salud.unm.edu

    Emily McQuaid-Hanson

    Recruiting

  • University of Colorado Hospital

    Arvada, Colorado, 80007

    Cristina Wood, MD, Cristina.wood@cuanschutz.edu

    Cristina Wood, MD

    Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

    Shobana Bharadwaj, MD, sbharadwaj@som.umaryland.edu

    Shobana Bharadwaj

    Recruiting

  • St Lukes Anesthesia Associates of Boise

    Boise, Idaho, 83712

    Allen Botimer, MD, abotimer@anesthesiaofboise.com

    Allen Botimer, MD

    Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

    Noor Reel, nraheel@bwh.harvard.edu

    Sharon Reale, MD

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Mark Norris, MD, Mark.Norris@bmc.org

    Mark Norris, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Yunping Li, MD, yli1@bidmc.harvard.edu

    Phillip Hess

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Haley Nitchie, nitchie@musc.edu

    Katherine Hatter, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Jessica Sheeran, MD, js5cu@uvahealth.org

    Jessica Sheeran, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Somayeh Mohammadi, mohammadis@bsd.uchicago.edu

    Caroline Thomas, MD

    Recruiting

  • University o Cincinnati

    Cincinnati, Ohio, 45267

    Andrea Girnius, MD, girniuaa@ucmail.uc.edu

    Andrea Girnius, MD

    Recruiting

  • Ohio State University/Wexner Medical Center

    Columbus, Ohio, 43214

    Completed

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Ashraf Habib, MD, Ashraf.habib@duke.edu

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Amy Gunnett, agunnett@anest.ufl.edu

    Adam Wendling, MD

    Recruiting

  • University of Texas-Houston

    Houston, Texas, 77030

    Barbara Orlando, MD, Barbara.Orlando@uth.tmc.edu

    Barbara Orlando, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Angie Plummer, plummera@iu.edu

    Sapna Ravindranath, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Cynthia Wong, cynthia-wong@uiowa.edu

    Adeeb Oweidat, MD

    Recruiting

  • University of Kansas Health System

    Kansas City, Kansas, 66160

    Grace Shih, MD, GSHIH@kumc.edu

    Grace Shih, MD

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Johanna Cobb, MD, Johanna.G.Cobb@hitchcock.org

    Recruiting

  • University of Arkansas

    Little Rock, Arkansas, 72205

    Nadir Sharawi, MD, nelsharawi@uams.edu

    Nadir Sharawi

    Recruiting

  • Northwell Health

    Manhasset, New York, 11030

    Andrea Ruggerio, aruggiero3@northwell.edu

    Greg Palleschi, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Holly Ende, MD, holly.ende@vumc.org

    Holly Ende, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06510

    Ricarda Tomlin, ricarda.tomlin@yale.edu

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Nakiyah Knibbs, MD, nakiyah.knibbs@mountsinai.org

    Nakiyah Knibbs

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Alexandra Nicholas, MD, 412-641-1778

    Alenandra Nicholas

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97035

    Sarah Feller, fellersa@ohsu.edu

    Brandon Tagioka, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Emily Sharpe, MD, sharpe.emily@mayo.edu

    Emily Sharpe, MD

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    Jillene Sturgess-Daprato, Jillene.Sturgess-Daprato@ucsf.edu

    Won Lee, MD

    Recruiting

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

    Amber Benhardt, 314-814-0802, amber.benhardt@mercy.net

    Amber Benhardt

    Recruiting

  • Stanford University

    Stanford, California, 94303

    Mina Michel, gmichel5@stanford.ed

    Brendan Carvalho, MD

    Recruiting

  • Renaissance School of Medicine Stony Brook University

    Stony Brook, New York, 11794

    Ayesha Khan, ayesha.khan@stonybrookmedicine.edu

    Tiffany Angelo, MD

    Recruiting

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508

    Michael Hofkamp, michael.hofkamp@bswhealth.org

    Michael Hofkamp

    Recruiting

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Lynne Harris, lcharris@wakehealth.edu

    Laura Dean, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Royal Columbian Hospital & University of British Columbia

    New Westminster

    Michelle Mozel, Michelle.Mozel@fraserhealth.ca

    Barry Thorneloe, MD

    Recruiting

Other trials in Canada

About this study

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.

Read the 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. 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.

    Measured: Up to 5 years

  4. 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.

    Measured: Up to 5 years

  5. 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.

    Measured: Up to 5 years

  6. 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.

    Measured: Up to 5 years

  7. 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.

    Measured: Up to 5 years

Secondary outcomes (6)

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

    Among the cohort of general anesthetics for cesarean delivery, the incidence of difficult intubation will be determined.

    Measured: Up to 5 years

  2. Univariate Association Between Mallampati Score and the Risk of Difficult Intubation

    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.

    Measured: Up to 5 years

  3. Univariate Association Between Neck Mobility and the Risk of Difficult Intubation

    The association between neck mobility- full (reference) vs. limited vs. poor and a difference in risk of difficult intubation will be assessed.

    Measured: Up to 5 years

  4. Univariate Association Between Neck Circumference and the Risk of Difficult Intubation

    The association between neck circumference- thin or average (reference) vs. thick and a difference in risk of difficult intubation will be assessed.

    Measured: Up to 5 years

  5. Univariate Association Between Neck Length and the Risk of Difficult Intubation

    The association between neck length- long or average (reference) vs. short and a difference in risk of difficult intubation will be assessed.

    Measured: Up to 5 years

  6. Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation

    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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start22 Feb 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Retrospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06030063
Sponsor's protocol ID
2000033638
Status last verified
Jun 2026
First submitted
16 Aug 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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