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RecruitingNCT06963047Updated Jun 16, 2026

Evaluation of Blood Loss After Cesarean Delivery Via US Compared to Standard Care

An interventional study of Ultrasound and Standard care in Postpartum Period, sponsored by Holy Family Hospital, Nazareth, Israel. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Holy Family Hospital, Nazareth, Israel · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Postpartum Period

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Keywords

  • Postpartum anemia
  • Postpartum hemorrhage
  • Ultrasound
  • Cesarean section
  • Intra-abdominal bleeding
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women who delivered by a cesarean section.
  • Age over 18.
  • Fluent in Hebrew or Arabic.
  • Signed informed consent form.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
276 participants (estimated)

Study arms

  • Active comparator
    Ultrasound group

    Group 1: patients will undergo an abdominal and transvaginal ultrasound examination within 24 - 48 hours post-surgery.

    Diagnostic Test: Ultrasound

  • Active comparator
    Standard care group

    Group 2: Candidates will be managed according to the standard care, i.e., without a routine postpartum ultrasound.

    Other: Standard care

Interventions

  • Diagnostic testUltrasound

    The purpose of the test is to diagnose and assess the amount of blood loss.

  • OtherStandard care

    Routine management

05

What researchers measure

Primary outcomes

  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.

    Time frame: 24 -72 hours

Secondary outcomes

  1. HB levels after 48-72

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

    Time frame: 72 hours postpartum

  2. Inferior Vena Cava (IVC) diameter

    Measurement of IVC diameter during inspiration and expiration

    Time frame: up to 72 hours postpartum

  3. IVC collapsibility index

    IVC expiration-IVC inspiration/IVC expiration

    Time frame: up to 72 hours postpartum

  4. Uterine walls diameter

    Measured midway between the fundus and the cervix of the uterus

    Time frame: up to 72 hours postpartum

  5. Uterine endometrial diameter

    Measuring the thickness of the inner layer of the uterus

    Time frame: up to 72 hours postpartum

  6. Uterine length

    Measured from the external cervical os to the fundus

    Time frame: up to 72 hours postpartum

  7. Maximum vertical depth of intra-abdominal fluid

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

    Time frame: up to 72 hours postpartum

  8. Urine volume in the bladder

    The measurement will be performed using an abdominal or vaginal transducer

    Time frame: 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

    Time frame: up to 72 hours postpartum

  10. Intra-abdominal fluid volume

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

    Time frame: up to 72 hours postpartum

  11. Presence of intra-abdominal hematomas

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

    Time frame: 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).

    Time frame: up to 72 hours postpartum

  13. Administration of blood products

    Number of blood units administrated

    Time frame: up to 72 hours postpartum

  14. Postoperative fever

    Maternal fever 38C or more

    Time frame: 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

    Time frame: Postoperative day 2 to day 7.

  16. Length of hospital stay

    Number of days from delivery to discharge

    Time frame: 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).

    Time frame: 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

    Time frame: 6 weeks postpartum

06

Study locations

1 of 1 sites recruiting
  • Holy family hospital
    Nazareth, North, Israel
    • Bassam A Abboud, MD · Contact · Dr.bassamabb@gmail.com · +972526792999
    • Bassam A Abboud, MD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06963047
Lead sponsor
Holy Family Hospital, Nazareth, Israel
Responsible party
Raed Salim, MD (Head of obstetrics and gynecology departement, Holy Family Hospital, Nazareth, Israel) — Principal investigator
First posted
May 8, 2025
Start date
May 8, 2025
Primary completion
May 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jun 16, 2026

Study contacts

Raed Sa, MD
Contact
r.salim@hfhosp.org
+972544986960
Bassam Abboud, MD
Contact
Dr.bassamabb@gmail.com
+972526792999
Raed Salim, MD
study chair · Holy Family Hospital, Nazareth, Israel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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