Fetal Outcomes Among Pregnant Emergency General Surgery Patients

NCT05085353 | Completed

• 1 other identifier: 076.TRA.2019.D
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Acute Appendicitis; Acute Cholecystitis; Biliary Pancreatitis; Acute Diverticulitis; Bowel Obstruction

Outcome Measures

Primary Outcomes (4)

• past medical history/comorbidities

  Baseline demographics

  birth to 30 days

• prenatal care prior to surgery

  Baseline demographics

  birth to 30 days

• medical care within one year of conception

  Baseline demographics

  birth to 30 days

• disease process

  Baseline demographics

  birth to 30 days

Interventions

non-obstetric acute general surgical disease PROCEDURE

non-obstetric acute general surgical disease

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women 18 or older with non-obstetric acute general surgical disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Pregnant women 18 or older with non-obstetric acute general surgical disease (Acute appendicitis, Acute cholecystitis, Acute biliary pancreatitis, Bowel obstruction, Acute diverticulitis

You may not qualify if:

• Trauma patients

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Trauma Center at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Appendicitis; Cholecystitis, Acute; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases

Study Officials

• Jennifer Burris, MD

  Trauma Center at Methodist Dallas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: February 25, 2020
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)