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OpenTrials
Completed

NCT Number: NCT05085353

Fetal Outcomes Among Pregnant Emergency General Surgery Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-obstetric acute general surgical disease

Procedure

non-obstetric acute general surgical disease

Primary outcomes

  1. past medical history/comorbidities

    Time frame: birth to 30 days

    Baseline demographics

  2. prenatal care prior to surgery

    Time frame: birth to 30 days

    Baseline demographics

  3. medical care within one year of conception

    Time frame: birth to 30 days

    Baseline demographics

  4. disease process

    Time frame: birth to 30 days

    Baseline demographics

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Fetal Outcomes Among Pregnant Emergency General Surgery Patients: a Prospective Multi-center Evaluation of Pregnant Patients Undergoing Emergency General Surgery

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 20, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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