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NCT Number: NCT06030063

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

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.

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Key information

Conditions

Cesarean Delivery General Anesthesia

Age range

15 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Royal Columbian Hospital & University of British Columbia, New Westminster, Canada

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About this study

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:

  • To determine the institutional factors associated with rates of general anesthesia for cesarean delivery
  • To perform a descriptive analysis of characteristics of general anesthesia for cesarean delivery cases
  • 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:

  • Pregnant women who have had a general anesthetic for Cesarean delivery
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Leffert, MD

CONTACT

[email protected]

(203)785-4304

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 8, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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