Postpartum PeriodNCT06963047
Evaluation of Blood Loss After Cesarean Delivery Via US Compared to Standard Care
A study testing Ultrasound in people with Postpartum Period, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.
Trial summary
Postpartum hemorrhage and anemia are considered a major health concern due to their impact on maternal morbidity and mortality, quality of life, and maternal cognitive and emotional functioning after delivery, which are particularly important during the critical period of mother-child bonding. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteIsrael
- Study dates
- 8 May 2025to 1 Jun 2027
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who delivered by a cesarean section.
- Age over 18.
- Fluent in Hebrew or Arabic.
- Signed informed consent form.
Who cannot join
- Lack of consent or inability to provide informed consent.
- Inability to perform a post-surgical ultrasound, such as post-surgery hospitalization in the intensive care unit.
- Women with preoperative coagulation disorders.
- Women whose clinical condition requires a post-cesarean ultrasound examination.
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, North
Bassam A Abboud, MD, +972526792999, Dr.bassamabb@gmail.com
Bassam A Abboud, MD
About this study
Official title: Ultrasound Use Compared With Standard Care for Diagnosis of Blood Loss After Cesarean Delivery: A Randomized Controlled Trial
Postpartum hemorrhage and anemia are considered a major health concern due to their impact on maternal morbidity and mortality, quality of life, and maternal cognitive and emotional functioning after delivery, which are particularly important during the critical period of mother-child bonding. Hemoglobin levels in the first 24 hours after delivery do not reflect the lowest point (nadir). The postpartum nadir occurs 48-72 hours after delivery due to the initial redistribution of plasma volume. The aim of this study was to examine whether postpartum ultrasound examination precedes laboratory test results in the diagnosis of anemia due to blood loss after cesarean section.
Read the detailed description
According to the World Health Organization, postpartum anemia should be recognized as a major health concern, as it affects the quality of life, cognitive and emotional function of the mother, which are particularly important during the critical period of mother-child bonding. Additionally, anemia may impact mother-infant interaction, potentially leading to cognitive delays in infants. Furthermore, postpartum anemia increases the risk of postpartum depression, the need for blood transfusions, length of hospital stays, and hospitalization costs.
Hemoglobin (HB) levels within the first 24 hours postpartum do not reflect the lowest point (nadir). The postpartum nadir occurs 48-72 hours after birth due to initial plasma volume redistribution. Diagnosis is made by measuring HB levels, and anemia is defined when HB is below 10 g at 48 hours postpartum. Postpartum anemia requires immediate treatment upon diagnosis and preferably before discharge.
The incidence of postpartum anemia in developing countries is 50-80%. This high incidence reflects a combination of reasons including under or late diagnosis, lack of awareness, and early hospital discharge.
Postpartum hemorrhage, particularly after cesarean section (CS), is a leading cause of postpartum anemia (HB <10 g%) as well as significant morbidity and mortality. When bleeding occurs into the abdominal cavity, diagnosis is more difficult and delayed, often only detected when vital signs become unstable. Early diagnosis is crucial for proper management of blood loss and life-saving interventions. Diagnosis includes laboratory tests and imaging modalities, and treatment is determined based on severity, ranging from iron supplementation, blood transfusions, and even surgical interventions if necessary.
A certain amount of intra-abdominal fluid is common after most CS. However, there is no standardized reference in gynecological literature regarding what fluid volume is considered normal or pathological after surgery, nor its association with complications such as pain, infection, or prolonged hospitalization. Studies have shown that free intra-abdominal fluid was detected in 73% of patients after CS using CT scans, whereas ultrasound (US) detected fluid in less than 5% of women.
Recently, advanced US technology has become available, including 3D imaging and Doppler technology, which allows for quantitative fluid volume assessment. US is considered a valuable tool for rapid assessment of intra-abdominal free fluid. It is a safe, fast, and non-invasive diagnostic modality that can be used in post-cesarean women to detect and measure intra-abdominal and pelvic fluid, causing minimal patient discomfort. US has several advantages over CT scans and most gynecology departments are equipped with US machines, and gynecologists are trained to use them in clinical practice.
Currently, there is no routine use of US to assess intra-abdominal fluid volume after CS. HB levels are only measured 24 hours post-surgery, which does not necessarily reflect the nadir value. After discharge, many postpartum women may not take iron supplements due to unrecognized anemia, poor tolerance, or low adherence. The aim of this study was to examine whether postpartum ultrasound examination compared to standard care, precedes laboratory test results in the diagnosis of anemia due to blood loss after CS.
- Conditions
- Postpartum Period
- Being tested
- Ultrasound, Standard care
- Keywords
- Postpartum anemia, Postpartum hemorrhage, Ultrasound, Cesarean section, Intra-abdominal bleeding
- Medical subject headings
- Postpartum Hemorrhage, Hemoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
The purpose of the test is to diagnose and assess the amount of blood loss.
Standard careOther
Routine management
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Active comparator | Group 1: patients will undergo an abdominal and transvaginal ultrasound examination within 24 - 48 hours post-surgery. Receives: Diagnostic Test: Ultrasound |
| Standard care group | Active comparator | Group 2: Candidates will be managed according to the standard care, i.e., without a routine postpartum ultrasound. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin drop of 2g% or more within 24 - 36 hours
The proportion of women with a decrease in Hb levels of over 2 g% identified within 24 hours of surgery in both groups.
Measured: 24 -72 hours
Secondary outcomes (18)
HB levels after 48-72
Difference in average HB levels after 48-72 hours between the two study groups
Measured: 72 hours postpartum
Inferior Vena Cava (IVC) diameter
Measurement of IVC diameter during inspiration and expiration
Measured: up to 72 hours postpartum
IVC collapsibility index
IVC expiration-IVC inspiration/IVC expiration
Measured: up to 72 hours postpartum
Uterine walls diameter
Measured midway between the fundus and the cervix of the uterus
Measured: up to 72 hours postpartum
Uterine endometrial diameter
Measuring the thickness of the inner layer of the uterus
Measured: up to 72 hours postpartum
Uterine length
Measured from the external cervical os to the fundus
Measured: up to 72 hours postpartum
Maximum vertical depth of intra-abdominal fluid
The measurement will be performed using abdominal and/or vaginal transducer
Measured: up to 72 hours postpartum
Urine volume in the bladder
The measurement will be performed using an abdominal or vaginal transducer
Measured: up to 72 hours postpartum
Rate of women in the study group with intra-abdominal fluid
The measurement will be performed using abdominal and/or vaginal transducer
Measured: up to 72 hours postpartum
Intra-abdominal fluid volume
The assessment will be performed using abdominal and/or vaginal transducer
Measured: up to 72 hours postpartum
Presence of intra-abdominal hematomas
The assessment will be performed using abdominal and/or vaginal transducer
Measured: up to 72 hours postpartum
Objective assessment of intraoperative blood loss
Calculated blood loss = total blood volume × (prepartum hematocrit - postpartum hematocrit) + total blood volume transfused (if applicable).
Measured: up to 72 hours postpartum
Administration of blood products
Number of blood units administrated
Measured: up to 72 hours postpartum
Postoperative fever
Maternal fever 38C or more
Measured: up to 72 hours postpartum
Incidence of women with surgical site infection
An infection in the part of the body where a surgery took place
Measured: Postoperative day 2 to day 7.
Length of hospital stay
Number of days from delivery to discharge
Measured: up to 10 days postpartum
Maternal discomfort during the ultrasound examination
Measured on a scale of 1 to 5 (1 = no discomfort, 5 = very uncomfortable).
Measured: up to 72 hours postpartum
HB levels after 4 - 6 weeks
Difference in average HB levels 4 - 6 weeks between the two study groups
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start8 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PeriodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
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
- NCT06963047
- Sponsor's protocol ID
- 309-2025-HFH
- Status last verified
- Jun 2026
- First submitted
- 19 Apr 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Use Compared With Standard Care for Diagnosis of Blood Loss After Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06963047
- Acronym / sponsor ID
- 309-2025-HFH
- Conditions
- Postpartum Period
- Keywords
- Postpartum anemia, Postpartum hemorrhage, Ultrasound, Cesarean section, Intra-abdominal bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Holy Family Hospital, Nazareth, IsraelUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 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.
Postpartum hemorrhage and anemia are considered a major health concern due to their impact on maternal morbidity and mortality, quality of life, and maternal cognitive and emotional functioning after delivery, which are particularly important during the critical period of mother-child bonding. Hemoglobin levels in the first 24 hours after delivery do not reflect the lowest point (nadir). The postpartum nadir occurs 48-72 hours after delivery due to the initial redistribution of plasma volume. The aim of this study was to examine whether postpartum ultrasound examination precedes laboratory test results in the diagnosis of anemia due to blood loss after cesarean section.
Detailed description
According to the World Health Organization, postpartum anemia should be recognized as a major health concern, as it affects the quality of life, cognitive and emotional function of the mother, which are particularly important during the critical period of mother-child bonding. Additionally, anemia may impact mother-infant interaction, potentially leading to cognitive delays in infants. Furthermore, postpartum anemia increases the risk of postpartum depression, the need for blood transfusions, length of hospital stays, and hospitalization costs.
Hemoglobin (HB) levels within the first 24 hours postpartum do not reflect the lowest point (nadir). The postpartum nadir occurs 48-72 hours after birth due to initial plasma volume redistribution. Diagnosis is made by measuring HB levels, and anemia is defined when HB is below 10 g at 48 hours postpartum. Postpartum anemia requires immediate treatment upon diagnosis and preferably before discharge.
The incidence of postpartum anemia in developing countries is 50-80%. This high incidence reflects a combination of reasons including under or late diagnosis, lack of awareness, and early hospital discharge.
Postpartum hemorrhage, particularly after cesarean section (CS), is a leading cause of postpartum anemia (HB <10 g%) as well as significant morbidity and mortality. When bleeding occurs into the abdominal cavity, diagnosis is more difficult and delayed, often only detected when vital signs become unstable. Early diagnosis is crucial for proper management of blood loss and life-saving interventions. Diagnosis includes laboratory tests and imaging modalities, and treatment is determined based on severity, ranging from iron supplementation, blood transfusions, and even surgical interventions if necessary.
A certain amount of intra-abdominal fluid is common after most CS. However, there is no standardized reference in gynecological literature regarding what fluid volume is considered normal or pathological after surgery, nor its association with complications such as pain, infection, or prolonged hospitalization. Studies have shown that free intra-abdominal fluid was detected in 73% of patients after CS using CT scans, whereas ultrasound (US) detected fluid in less than 5% of women.
Recently, advanced US technology has become available, including 3D imaging and Doppler technology, which allows for quantitative fluid volume assessment. US is considered a valuable tool for rapid assessment of intra-abdominal free fluid. It is a safe, fast, and non-invasive diagnostic modality that can be used in post-cesarean women to detect and measure intra-abdominal and pelvic fluid, causing minimal patient discomfort. US has several advantages over CT scans and most gynecology departments are equipped with US machines, and gynecologists are trained to use them in clinical practice.
Currently, there is no routine use of US to assess intra-abdominal fluid volume after CS. HB levels are only measured 24 hours post-surgery, which does not necessarily reflect the nadir value. After discharge, many postpartum women may not take iron supplements due to unrecognized anemia, poor tolerance, or low adherence. The aim of this study was to examine whether postpartum ultrasound examination compared to standard care, precedes laboratory test results in the diagnosis of anemia due to blood loss after CS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Active comparator | Diagnostic Test: UltrasoundGroup 1: patients will undergo an abdominal and transvaginal ultrasound examination within 24 - 48 hours post-surgery. |
| Standard care group | Active comparator | Other: Standard careGroup 2: Candidates will be managed according to the standard care, i.e., without a routine postpartum ultrasound. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women who delivered by a cesarean section.
- Age over 18.
- Fluent in Hebrew or Arabic.
- Signed informed consent form.
Key exclusion criteria (4 listed)
- Lack of consent or inability to provide informed consent.
- Inability to perform a post-surgical ultrasound, such as post-surgery hospitalization in the intensive care unit.
- Women with preoperative coagulation disorders.
- Women whose clinical condition requires a post-cesarean ultrasound examination.
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 |
|---|---|---|
| UltrasoundThe purpose of the test is to diagnose and assess the amount of blood loss. | Diagnostic test | Ultrasound group |
| Standard careRoutine management | Other | Standard care group |
Primary outcome
Hemoglobin drop of 2g% or more within 24 - 36 hours
Time frame: 24 -72 hours
The proportion of women with a decrease in Hb levels of over 2 g% identified within 24 hours of surgery in both groups.
18 secondary outcomes
HB levels after 48-72
Time frame: 72 hours postpartum
Inferior Vena Cava (IVC) diameter
Time frame: up to 72 hours postpartum
IVC collapsibility index
Time frame: up to 72 hours postpartum
Uterine walls diameter
Time frame: up to 72 hours postpartum
Uterine endometrial diameter
Time frame: up to 72 hours postpartum
Uterine length
Time frame: up to 72 hours postpartum
Maximum vertical depth of intra-abdominal fluid
Time frame: up to 72 hours postpartum
Urine volume in the bladder
Time frame: up to 72 hours postpartum
Rate of women in the study group with intra-abdominal fluid
Time frame: up to 72 hours postpartum
Intra-abdominal fluid volume
Time frame: up to 72 hours postpartum
Presence of intra-abdominal hematomas
Time frame: up to 72 hours postpartum
Objective assessment of intraoperative blood loss
Time frame: up to 72 hours postpartum
Administration of blood products
Time frame: up to 72 hours postpartum
Postoperative fever
Time frame: up to 72 hours postpartum
Incidence of women with surgical site infection
Time frame: Postoperative day 2 to day 7.
Length of hospital stay
Time frame: up to 10 days postpartum
Maternal discomfort during the ultrasound examination
Time frame: up to 72 hours postpartum
HB levels after 4 - 6 weeks
Time frame: 6 weeks postpartum
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 16 Jun 2026.
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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?
A study testing Ultrasound in people with Postpartum Period, 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 4 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 16 Jun 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 Sa, 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?
Hemoglobin drop of 2g% or more within 24 - 36 hours (time frame: 24 -72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.