Post-Operative Hematoma at Operative Site (Diagnosis)NCT06953141
Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery
An observational study of Post-Operative Hematoma at Operative Site (Diagnosis) and Post-Operative Hemorrhage, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Post-Operative Hematoma at Operative Site (Diagnosis), Post-Operative Hemorrhage
- What is being tested?
- Ultrasound
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 8 May 2025to 15 Dec 2026
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
Study population: Women aged 18 years and older undergoing gynecological surgery (open, laparoscopic, or vaginal) at Holy Family Hospital in Nazareth, Israel.
Who may be able to join
- Women aged 18 years and older
- Undergoing gynecological surgery including laparotomy, laparoscopy, and vaginal pelvic surgery
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Holy Family hospital, Nazareth
Nazareth
Reem Younis, MD, +972528328002, Reemyounis010@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasound
- Medical subject headings
- Disease, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Transabdominal and transvaginal imaging will be performed to eligible women following gynecological surgery within 24 - 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Abdominal and transvaginal ultrasound Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24-48 hours after surgery
Secondary outcomes (9)
Volume of intra-abdominal fluid
Measured in mL using 3D ultrasound
Measured: Within 24-48 hours after surgery
Presence and size of pelvic hematoma
Using ultrasound to identify hematomas and measure their volume
Measured: 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
Measured: Within 24-48 hours after surgery
Hemoglobin drop
Delta hemoglobin level before surgery and at 48-72 hours postoperatively.
Measured: Within 24-48 hours after surgery
Need for blood transfusion
Number of packed red blood cells administered during hospitalization.
Measured: Within 72 hours after surgery
Length of hospital stay
Total duration of hospitalization in days.
Measured: Day 1 to day 7 after operation
Surgical site infection
Recording any infection in the part of the body where a surgery took place
Measured: Within 96 hours after surgery
Postoperative fever
Body temperature ≥38.0°C within 72 hours after surgery.
Measured: 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).
Measured: Immediately after ultrasound examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start8 May 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Operative Hematoma at Operative Site (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Holy Family Hospital, Nazareth, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raed Salim, MD, Holy Family Hospital, Nazareth, Israel
- Investigators
- Raed Salim, MD, Study chair, Holy Family Hospital, Nazareth, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953141
- Sponsor's protocol ID
- 308-2025-HFH
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34076923Faustin 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.
PubMed 3895070Naeiji 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.
PubMed 30957592Antonelli 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.
PubMed 15065191Hoppenot 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.
PubMed 26302357Dane 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.
PubMed 17485823
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Use to Estimate the Amount of Intra-abdominal Blood Following Gynecological Surgeries and the Association With Postoperative Outcomes. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06953141
- Acronym / sponsor ID
- 308-2025-HFH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Holy Family Hospital, Nazareth, IsraelUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: UltrasoundAbdominal and transvaginal ultrasound |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years and older undergoing gynecological surgery (open, laparoscopic, or vaginal) at Holy Family Hospital in Nazareth, Israel.
Key inclusion criteria (3 listed)
- Women aged 18 years and older
- Undergoing gynecological surgery including laparotomy, laparoscopy, and vaginal pelvic surgery
- Able to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundTransabdominal and transvaginal imaging will be performed to eligible women following gynecological surgery within 24 - 48 hours. | Diagnostic test | Study group |
Primary outcome
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.
9 secondary outcomes
Volume of intra-abdominal fluid
Time frame: Within 24-48 hours after surgery
Presence and size of pelvic hematoma
Time frame: Within 24-48 hours after surgery
Inferior vena cava (IVC) diameter and collapsibility index
Time frame: Within 24-48 hours after surgery
Hemoglobin drop
Time frame: Within 24-48 hours after surgery
Need for blood transfusion
Time frame: Within 72 hours after surgery
Length of hospital stay
Time frame: Day 1 to day 7 after operation
Surgical site infection
Time frame: Within 96 hours after surgery
Postoperative fever
Time frame: Within 96 hours after surgery
Patient discomfort from the ultrasound examination
Time frame: Immediately after ultrasound examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 34076923Massalha 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.
- Background: PubMed 3895070Faustin 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.
- Background: PubMed 30957592Naeiji 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.
- Background: PubMed 15065191Antonelli 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.
- Background: PubMed 26302357Hoppenot 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.
- Background: PubMed 17485823Dane 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raed Salim, MD study chair
Holy Family Hospital, Nazareth, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Operative Hematoma at Operative Site (Diagnosis) and Post-Operative Hemorrhage, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raed Salim, MD (+972544986960, r.salim@hfhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intra-abdominal free fluid (time frame: Within 24-48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953141, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.