Fetal Outcomes Among Pregnant Emergency General Surgery Patients

Pregnancy Complications Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Cholecystitis
• Acute Diverticulitis
• Appendicitis
• Biliary Pancreatitis
• Bowel Obstruction
• Cholecystitis
• Cholecystitis, Acute
• Diverticulitis
• Emergencies
• Intestinal Obstruction
• Pancreatitis
• Pregnancy Complications

• NCT number: NCT05085353
• Study type: Observational [Patient Registry]
• Source: Methodist Health System
• Status: Enrolling by invitation
• Start date: February 25, 2020
• Completion date: February 25, 2025