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CompletedNCT05085353Updated Mar 27, 2026

Fetal Outcomes Among Pregnant Emergency General Surgery Patients

An observational study in Pregnancy Complications, Acute Appendicitis and Acute Cholecystitis, sponsored by Methodist Health System. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed 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.
02

Conditions studied

  • Pregnancy Complications
  • Acute Appendicitis
  • Acute Cholecystitis
  • Biliary Pancreatitis
  • Bowel Obstruction
  • Acute Diverticulitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Trauma patients
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

Interventions

  • Procedurenon-obstetric acute general surgical disease

    non-obstetric acute general surgical disease

05

What researchers measure

Primary outcomes

  1. past medical history/comorbidities

    Baseline demographics

    Time frame: birth to 30 days

  2. prenatal care prior to surgery

    Baseline demographics

    Time frame: birth to 30 days

  3. medical care within one year of conception

    Baseline demographics

    Time frame: birth to 30 days

  4. disease process

    Baseline demographics

    Time frame: birth to 30 days

06

Study locations

1 site
  • Trauma Center at Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
07

Registry details

Key details

Study ID
NCT05085353
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Oct 20, 2021
Start date
Feb 25, 2020
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025
Last update
Mar 27, 2026

Study contacts

Jennifer Burris, MD
principal investigator · Trauma Center at Methodist Dallas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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