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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05085353
• Other study ID #: 076.TRA.2019.D
• Status: Enrolling by invitation
• Start date: February 25, 2020
• Est. completion date: February 25, 2025

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: February 25, 2025
• Est. primary completion date: February 25, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Procedure:
• non-obstetric acute general surgical disease
non-obstetric acute general surgical disease

Locations

Country	Name	City	State
United States	Trauma Center at Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	past medical history/comorbidities	Baseline demographics	birth to 30 days
Primary	prenatal care prior to surgery	Baseline demographics	birth to 30 days
Primary	medical care within one year of conception	Baseline demographics	birth to 30 days
Primary	disease process	Baseline demographics	birth to 30 days