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NCT Number: NCT06953141

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

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.

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Key information

Conditions

Post-Operative Hematoma at Operative Site (Diagnosis) Disease Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Operative Hemorrhage Postoperative Complications Postoperative Hemorrhage

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

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

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

Treatment and study plan

Ultrasound

Diagnostic Test

Transabdominal and transvaginal imaging will be performed to eligible women following gynecological surgery within 24 - 48 hours.

Primary outcomes

  1. Incidence of intra-abdominal free fluid

    Time frame: Within 24-48 hours after surgery

    Detection of any intra-abdominal or pelvic free fluid via ultrasound examination within 24 - 48 hours after gynecological surgery.

Secondary outcomes

  1. Volume of intra-abdominal fluid

    Time frame: Within 24-48 hours after surgery

    Measured in mL using 3D ultrasound

  2. Presence and size of pelvic hematoma

    Time frame: Within 24-48 hours after surgery

    Using ultrasound to identify hematomas and measure their volume

  3. Inferior vena cava (IVC) diameter and collapsibility index

    Time frame: Within 24-48 hours after surgery

    Using ultrasound Doppler to measure Inferior vena cava (IVC) diameter and collapsibility index

  4. Hemoglobin drop

    Time frame: Within 24-48 hours after surgery

    Delta hemoglobin level before surgery and at 48-72 hours postoperatively.

  5. Need for blood transfusion

    Time frame: Within 72 hours after surgery

    Number of packed red blood cells administered during hospitalization.

  6. Length of hospital stay

    Time frame: Day 1 to day 7 after operation

    Total duration of hospitalization in days.

  7. Surgical site infection

    Time frame: Within 96 hours after surgery

    Recording any infection in the part of the body where a surgery took place

  8. Postoperative fever

    Time frame: Within 96 hours after surgery

    Body temperature ≥38.0°C within 72 hours after surgery.

  9. Patient discomfort from the ultrasound examination

    Time frame: Immediately after ultrasound examination

    Measured on a scale of 1 to 5 (1 = no discomfort, 5 = very uncomfortable).

Study contacts

Contact information is provided by the study sponsor or research team.

Raed Salim, MD

CONTACT

[email protected]

+972544986960

Reem Younis, MD

CONTACT

[email protected]

+972528328002

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Nazareth, Israel

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
Apr 13, 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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