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Fetal Outcomes Among Pregnant Emergency General Surgery Patients

Fetal Outcomes Among Pregnant Emergency General Surgery Patients: a Prospective Multi-center Evaluation of Pregnant Patients Undergoing Emergency General Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05085353
Enrollment
3
Registered
2021-10-20
Start date
2020-02-25
Completion date
2025-06-12
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis, Acute Cholecystitis, Acute Diverticulitis, Biliary Pancreatitis, Bowel Obstruction, Pregnancy Complications

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.

Interventions

PROCEDUREnon-obstetric acute general surgical disease

non-obstetric acute general surgical disease

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
past medical history/comorbiditiesbirth to 30 daysBaseline demographics
prenatal care prior to surgerybirth to 30 daysBaseline demographics
medical care within one year of conceptionbirth to 30 daysBaseline demographics
disease processbirth to 30 daysBaseline demographics

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJennifer Burris, MD

Trauma Center at Methodist Dallas Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026