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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Bassam Abboud, MD contact

+972526792999

Dr.bassamabb@gmail.com

Israel1 site, 1 recruiting
  • Holy family hospital

    Nazareth, North

    Bassam A Abboud, MD, +972526792999, Dr.bassamabb@gmail.com

    Bassam A Abboud, MD

    Recruiting

Other trials in Israel

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.

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 groups in NCT06963047
Study groupRoleWhat they receive
Ultrasound groupActive comparatorGroup 1: patients will undergo an abdominal and transvaginal ultrasound examination within 24 - 48 hours post-surgery.
Receives: Diagnostic Test: Ultrasound
Standard care groupActive comparatorGroup 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.

  1. 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)
  1. HB levels after 48-72

    Difference in average HB levels after 48-72 hours between the two study groups

    Measured: 72 hours postpartum

  2. Inferior Vena Cava (IVC) diameter

    Measurement of IVC diameter during inspiration and expiration

    Measured: up to 72 hours postpartum

  3. IVC collapsibility index

    IVC expiration-IVC inspiration/IVC expiration

    Measured: up to 72 hours postpartum

  4. Uterine walls diameter

    Measured midway between the fundus and the cervix of the uterus

    Measured: up to 72 hours postpartum

  5. Uterine endometrial diameter

    Measuring the thickness of the inner layer of the uterus

    Measured: up to 72 hours postpartum

  6. Uterine length

    Measured from the external cervical os to the fundus

    Measured: up to 72 hours postpartum

  7. Maximum vertical depth of intra-abdominal fluid

    The measurement will be performed using abdominal and/or vaginal transducer

    Measured: up to 72 hours postpartum

  8. Urine volume in the bladder

    The measurement will be performed using an abdominal or vaginal transducer

    Measured: up to 72 hours postpartum

  9. 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

  10. Intra-abdominal fluid volume

    The assessment will be performed using abdominal and/or vaginal transducer

    Measured: up to 72 hours postpartum

  11. Presence of intra-abdominal hematomas

    The assessment will be performed using abdominal and/or vaginal transducer

    Measured: up to 72 hours postpartum

  12. 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

  13. Administration of blood products

    Number of blood units administrated

    Measured: up to 72 hours postpartum

  14. Postoperative fever

    Maternal fever 38C or more

    Measured: up to 72 hours postpartum

  15. 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.

  16. Length of hospital stay

    Number of days from delivery to discharge

    Measured: up to 10 days postpartum

  17. 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

  18. 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.

  1. First posted8 May 2025
  2. Study start8 May 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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)
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

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.

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