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

NCT06953141 | Recruiting DMC

• 1 other identifier: 308-2025-HFH
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Operative Hematoma at Operative Site (Diagnosis); Post-Operative Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Volume of intra-abdominal fluid

  Within 24-48 hours after surgery

• Presence and size of pelvic hematoma

  Within 24-48 hours after surgery

• Inferior vena cava (IVC) diameter and collapsibility index

  Within 24-48 hours after surgery

• Hemoglobin drop

  Within 24-48 hours after surgery

• Need for blood transfusion

  Within 72 hours after surgery

Study Arms (1)

Study group

Abdominal and transvaginal ultrasound

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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

Study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holy Family Hospital, Nazareth, Israel: lead

Study Sites (1)

Holy Family hospital, Nazareth

Nazareth, Israel

RECRUITING

Related Publications (6)

• 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.

  PMID: 34076923 BACKGROUND

• 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.

  PMID: 3895070 BACKGROUND

• 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.

  PMID: 30957592 BACKGROUND

• 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.

  PMID: 15065191 BACKGROUND

• 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.

  PMID: 26302357 BACKGROUND

• 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.

  PMID: 17485823 BACKGROUND

MeSH Terms

Conditions

Disease; Postoperative Hemorrhage

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Postoperative Complications

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Raed Salim, MD

  Holy Family Hospital, Nazareth, Israel

  STUDY CHAIR

Central Study Contacts

Raed Salim, MD

CONTACT

+972544986960; r.salim@hfhosp.org

Reem Younis, MD

CONTACT

+972528328002; reemyounis010@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Obstetrics and Gynecology Department

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 1, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IL (1)