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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05085353
Other study ID # 076.TRA.2019.D
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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