Brief Title
Fetal Outcomes Among Pregnant Emergency General Surgery Patients
Official Title
Fetal Outcomes Among Pregnant Emergency General Surgery Patients: a Prospective Multi-center Evaluation of Pregnant Patients Undergoing Emergency General Surgery
Brief Summary
Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the
pregnant woman raises concern for complications adversely affecting pregnancy outcomes. The
most common reason for surgery is acute appendicitis followed by gallbladder disease. Despite
the common incidence of non-obstetric surgery among pregnant women, little is known regarding
fetal outcome and the impact of laparoscopic interventions versus traditional open
procedures. Even less is known about the role of non-operative management of general surgical
disease in the pregnant population. However, fetal outcome is not compromised by emergency
general surgery condition interventions.
Detailed Description
Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the
pregnant woman raises concern for complications adversely affecting pregnancy outcomes. The
most common reason for surgery is acute appendicitis followed by gallbladder disease. Despite
the common incidence of non-obstetric surgery among pregnant women, little is known regarding
fetal outcome and the impact of laparoscopic interventions versus traditional open
procedures. Even less is known about the role of non-operative management of general surgical
disease in the pregnant population. However, fetal outcome is not compromised by emergency
general surgery condition interventions. The primary objective of this study is to establish
best practices for management of pregnant patients requiring emergency non-obstetric general
surgery.
This is a prospective multi-center observational study of pregnant women and their
fetus/neonate (birth to 30 days) with acute general non-obstetric surgical diseases,
including those undergoing operative and non-operative management. Data collected will be
purely observational and involve no study-based therapeutic interventions or alterations in
patient care. The patients will be managed per institutional standard of care. Data
collection will occur in the following format:
- Initiated upon admission for general surgery until discharge for that admission
- Upon the birth of the child
- Post-delivery of the child, through that admission until discharged, for a maximum of 30
days post- delivery All of the data will be collected from the medical record, as long
as the subject's providers utilize EPIC. Otherwise, an approved member of the research
team may need to contact the patient via telephone to obtain access to their non-EPIC
record.
Study Type
Observational [Patient Registry]
Primary Outcome
past medical history/comorbidities
Condition
Pregnancy Complications
Intervention
non-obstetric acute general surgical disease
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
50
Start Date
February 25, 2020
Completion Date
February 2024
Primary Completion Date
February 2023
Eligibility Criteria
Inclusion Criteria:
- Pregnant women 18 or older with non-obstetric acute general surgical disease (Acute
appendicitis, Acute cholecystitis, Acute biliary pancreatitis, Bowel obstruction,
Acute diverticulitis
Exclusion Criteria:
- Trauma patients
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jennifer Burris, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05085353
Organization ID
076.TRA.2019.D
Responsible Party
Sponsor
Study Sponsor
Methodist Health System
Study Sponsor
Jennifer Burris, MD, Principal Investigator, Trauma Center at Methodist Dallas Medical Center
Verification Date
October 2021