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NCT Number: NCT06963047

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Holy family hospital

Nazareth, North, Israel

Location status: Recruiting

Location contact

Bassam A Abboud, MD

CONTACT

[email protected]

+972526792999

Bassam A Abboud, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Ultrasound

Diagnostic Test

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

Standard care

Other

Routine management

Primary outcomes

  1. 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.

Secondary outcomes

  1. HB levels after 48-72

    Time frame: 72 hours postpartum

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

  2. Inferior Vena Cava (IVC) diameter

    Time frame: up to 72 hours postpartum

    Measurement of IVC diameter during inspiration and expiration

  3. IVC collapsibility index

    Time frame: up to 72 hours postpartum

    IVC expiration-IVC inspiration/IVC expiration

  4. Uterine walls diameter

    Time frame: up to 72 hours postpartum

    Measured midway between the fundus and the cervix of the uterus

  5. Uterine endometrial diameter

    Time frame: up to 72 hours postpartum

    Measuring the thickness of the inner layer of the uterus

  6. Uterine length

    Time frame: up to 72 hours postpartum

    Measured from the external cervical os to the fundus

  7. Maximum vertical depth of intra-abdominal fluid

    Time frame: up to 72 hours postpartum

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

  8. Urine volume in the bladder

    Time frame: up to 72 hours postpartum

    The measurement will be performed using an abdominal or vaginal transducer

  9. Rate of women in the study group with intra-abdominal fluid

    Time frame: up to 72 hours postpartum

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

  10. Intra-abdominal fluid volume

    Time frame: up to 72 hours postpartum

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

  11. Presence of intra-abdominal hematomas

    Time frame: up to 72 hours postpartum

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

  12. Objective assessment of intraoperative blood loss

    Time frame: up to 72 hours postpartum

    Calculated blood loss = total blood volume × (prepartum hematocrit - postpartum hematocrit) + total blood volume transfused (if applicable).

  13. Administration of blood products

    Time frame: up to 72 hours postpartum

    Number of blood units administrated

  14. Postoperative fever

    Time frame: up to 72 hours postpartum

    Maternal fever 38C or more

  15. Incidence of women with surgical site infection

    Time frame: Postoperative day 2 to day 7.

    An infection in the part of the body where a surgery took place

  16. Length of hospital stay

    Time frame: up to 10 days postpartum

    Number of days from delivery to discharge

  17. Maternal discomfort during the ultrasound examination

    Time frame: up to 72 hours postpartum

    Measured on a scale of 1 to 5 (1 = no discomfort, 5 = very uncomfortable).

  18. HB levels after 4 - 6 weeks

    Time frame: 6 weeks postpartum

    Difference in average HB levels 4 - 6 weeks between the two study groups

Study contacts

Contact information is provided by the study sponsor or research team.

Bassam Abboud, MD

CONTACT

[email protected]

+972526792999

Raed Sa, MD

CONTACT

[email protected]

+972544986960

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Nazareth, Israel

Other

Registry information

Official study title

Ultrasound Use Compared With Standard Care for Diagnosis of Blood Loss After Cesarean Delivery: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 8, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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