Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery

Ultrasound Use to Estimate the Amount of Intra-abdominal Blood Following Gynecological Surgeries and the Association With Postoperative Outcomes. A Prospective Cohort Study

This is a prospective cohort study designed to assess intra-abdominal blood volume and hemodynamic status by measuring the diameter of the inferior vena cava (IVC) using 3D and Doppler ultrasound within 24 hours after gynecological surgery. The study will examine the association between these ultrasound findings and postoperative outcomes, including hemoglobin drop, need for blood transfusion, pain, infection, and length of hospitalization. Approximately 250 women undergoing laparotomy, laparoscopy, or vaginal surgery at Holy Family Hospital will be enrolled. The study also aimed to define postoperative normograms for fluid volume and IVC parameters and to evaluate whether ultrasound-guided decision-making could improve postoperative care and reduce unnecessary interventions.

Study Overview

• Status: Recruiting
• Conditions: Post-Operative Hematoma at Operative Site (Diagnosis); Post-Operative Hemorrhage
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

Postoperative intra-abdominal bleeding is a significant contributor to morbidity and, in some cases, mortality following gynecological surgery. Timely recognition of intra-abdominal blood loss is essential for appropriate clinical intervention. In cases where bleeding is into the abdominal cavity, diagnosis is more difficult and may be delayed.

Ultrasound is a non-invasive, rapid, and widely available tool for assessing free intra-abdominal and pelvic fluid. Modern machines allow for 3D volumetric assessment of fluid collections, as well as Doppler-based measurements of the inferior vena cava (IVC) diameter and its collapsibility index-both of which are known to correlate with intravascular volume status and blood loss. Currently, there are limited data establishing normal ranges of intra-abdominal fluid or IVC diameter postoperatively, and little is known about the magnitude of these measurements and clinical outcomes after gynecologic procedures.

This prospective cohort study aims to quantify intra-abdominal fluid and determine IVC diameter and its collapsibility index using advanced ultrasound imaging within 24 hours after surgery. Patients undergoing open, laparoscopic, or vaginal gynecological procedures will be included. The study will explore correlations between ultrasound findings and clinical outcomes such as hemoglobin drop, need for blood transfusion, infection, pain, and length of hospital stay. Additionally, we aim to develop reference normograms for postoperative normal ranges of intraabdominal fluid volume and IVC diameter.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Raed Salim, MD; Phone Number: +972544986960; Email: r.salim@hfhosp.org
• Study Contact Backup: Name: Reem Younis, MD; Phone Number: +972528328002; Email: Reemyounis010@gmail.com

Study Locations

• Israel
  • Nazareth, Israel
    • Recruiting
    • Holy Family hospital, Nazareth
    • Contact: Reem Younis, MD; Phone Number: +972528328002; Email: Reemyounis010@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years and older undergoing gynecological surgery (open, laparoscopic, or vaginal) at Holy Family Hospital in Nazareth, Israel.

Description

Inclusion Criteria:

• Women aged 18 years and older
• Undergoing gynecological surgery including laparotomy, laparoscopy, and vaginal pelvic surgery
• Able to provide informed consent

Exclusion Criteria:

• Undergoing minor procedures (e.g., dilation and curettage, hysteroscopy, or cervical conization)
• Known preoperative coagulation disorders
• Postoperative admission to the intensive care unit (ICU)
• Clinical indication requiring ultrasound as part of standard postoperative care

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Abdominal and transvaginal ultrasound	Diagnostic test: Ultrasound; Transabdominal and transvaginal imaging will be performed to eligible women following gynecological surgery within 24 - 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intra-abdominal free fluid	Detection of any intra-abdominal or pelvic free fluid via ultrasound examination within 24 - 48 hours after gynecological surgery.	Within 24-48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of intra-abdominal fluid	Measured in mL using 3D ultrasound	Within 24-48 hours after surgery
Presence and size of pelvic hematoma	Using ultrasound to identify hematomas and measure their volume	Within 24-48 hours after surgery
Inferior vena cava (IVC) diameter and collapsibility index	Using ultrasound Doppler to measure Inferior vena cava (IVC) diameter and collapsibility index	Within 24-48 hours after surgery
Hemoglobin drop	Delta hemoglobin level before surgery and at 48-72 hours postoperatively.	Within 24-48 hours after surgery
Need for blood transfusion	Number of packed red blood cells administered during hospitalization.	Within 72 hours after surgery
Length of hospital stay	Total duration of hospitalization in days.	Day 1 to day 7 after operation
Surgical site infection	Recording any infection in the part of the body where a surgery took place	Within 96 hours after surgery
Postoperative fever	Body temperature ≥38.0°C within 72 hours after surgery.	Within 96 hours after surgery
Patient discomfort from the ultrasound examination	Measured on a scale of 1 to 5 (1 = no discomfort, 5 = very uncomfortable).	Immediately after ultrasound examination

Collaborators and Investigators

• Sponsor: Holy Family Hospital, Nazareth, Israel
• Investigators: Study Chair: Raed Salim, MD, Holy Family Hospital, Nazareth, Israel

Publications and helpful links

General Publications

• Massalha M, Faranish R, Romano S, Salim R. Decreased inferior vena cava diameter as an early marker in postpartum hemorrhage. Ultrasound Obstet Gynecol. 2022 Feb;59(2):234-240. doi: 10.1002/uog.23695. Epub 2022 Jan 18.
• Faustin D, Minkoff H, Schaffer R, Crombleholme W, Schwarz R. Relationship of ultrasound findings after cesarean section to operative morbidity. Obstet Gynecol. 1985 Aug;66(2):195-8.
• Naeiji Z, Sotudeh S, Keshavarz E, Naghshvarian N, Rahmati N. Risk factors and clinical significance of abdomino-pelvic free fluid after cesarean section: a prospective study. J Matern Fetal Neonatal Med. 2021 Jan;34(2):287-292. doi: 10.1080/14767058.2019.1605351. Epub 2019 May 15.
• Antonelli E, Morales MA, Dumps P, Boulvain M, Weil A. Sonographic detection of fluid collections and postoperative morbidity following Cesarean section and hysterectomy. Ultrasound Obstet Gynecol. 2004 Apr;23(4):388-92. doi: 10.1002/uog.1023.
• Hoppenot C, Tankou J, Stair S, Gossett DR. Sonographic evaluation for intra-abdominal hemorrhage after cesarean delivery. J Clin Ultrasound. 2016 May;44(4):240-4. doi: 10.1002/jcu.22289. Epub 2015 Aug 24.
• Dane C, Dane B, Cetin A, Yayla M. Sonographically diagnosed vault hematomas following vaginal hysterectomy and its correlation with postoperative morbidity. Infect Dis Obstet Gynecol. 2009;2009:91708. doi: 10.1155/2007/91708. Epub 2007 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: April 19, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Hemorrhage; Pathological Conditions, Signs and Symptoms; Disease; Postoperative Hemorrhage; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 308-2025-HFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No