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
Verified date | March 2024 |
Source | Methodist Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Trauma Center at Methodist Dallas Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Methodist Health System |
United States,
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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