Fetal Outcomes Among Pregnant Emergency General Surgery Patients

• Conditions: Pregnancy Complications; Acute Appendicitis; Acute Cholecystitis; Biliary Pancreatitis; Acute Diverticulitis; Bowel Obstruction

• Registration Number: NCT05085353
• Lead Sponsor: Methodist Health System

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 Timeline

• Study Start: 2020-02-25
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-02-25
• Study Completion: 2025-02-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prenatal care prior to surgery	birth to 30 days	Baseline demographics
past medical history/comorbidities	birth to 30 days	Baseline demographics
medical care within one year of conception	birth to 30 days	Baseline demographics
disease process	birth to 30 days	Baseline demographics

Trial Locations

Locations (1)

Trauma Center at Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States