Clinical trial NCT05085353: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pregnancy Complications
Acute Appendicitis
Acute Cholecystitis
Biliary Pancreatitis
Bowel Obstruction
Acute Diverticulitis
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: past medical history/comorbidities
timeFrame: birth to 30 days
measure: prenatal care prior to surgery
timeFrame: birth to 30 days
measure: medical care within one year of conception
timeFrame: birth to 30 days
measure: disease process
timeFrame: birth to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Trauma Center at Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Trauma Center at Methodist Dallas Medical Center
name: Jennifer Burris, MD
role: PRINCIPAL_INVESTIGATOR
References: