Holy family hospital
Nazareth, North, Israel
Location status: Recruiting
Location contact
Bassam A Abboud, MD
CONTACT
Bassam A Abboud, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06963047
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Nazareth, North, Israel
Location status: Recruiting
Bassam A Abboud, MD
CONTACT
Bassam A Abboud, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The purpose of the test is to diagnose and assess the amount of blood loss.
Routine management
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.
Time frame: 72 hours postpartum
Difference in average HB levels after 48-72 hours between the two study groups
Time frame: up to 72 hours postpartum
Measurement of IVC diameter during inspiration and expiration
Time frame: up to 72 hours postpartum
IVC expiration-IVC inspiration/IVC expiration
Time frame: up to 72 hours postpartum
Measured midway between the fundus and the cervix of the uterus
Time frame: up to 72 hours postpartum
Measuring the thickness of the inner layer of the uterus
Time frame: up to 72 hours postpartum
Measured from the external cervical os to the fundus
Time frame: up to 72 hours postpartum
The measurement will be performed using abdominal and/or vaginal transducer
Time frame: up to 72 hours postpartum
The measurement will be performed using an abdominal or vaginal transducer
Time frame: up to 72 hours postpartum
The measurement will be performed using abdominal and/or vaginal transducer
Time frame: up to 72 hours postpartum
The assessment will be performed using abdominal and/or vaginal transducer
Time frame: up to 72 hours postpartum
The assessment will be performed using abdominal and/or vaginal transducer
Time frame: up to 72 hours postpartum
Calculated blood loss = total blood volume × (prepartum hematocrit - postpartum hematocrit) + total blood volume transfused (if applicable).
Time frame: up to 72 hours postpartum
Number of blood units administrated
Time frame: up to 72 hours postpartum
Maternal fever 38C or more
Time frame: Postoperative day 2 to day 7.
An infection in the part of the body where a surgery took place
Time frame: up to 10 days postpartum
Number of days from delivery to discharge
Time frame: up to 72 hours postpartum
Measured on a scale of 1 to 5 (1 = no discomfort, 5 = very uncomfortable).
Time frame: 6 weeks postpartum
Difference in average HB levels 4 - 6 weeks between the two study groups
Contact information is provided by the study sponsor or research team.
Bassam Abboud, MD
CONTACT
Raed Sa, MD
CONTACT
Holy Family Hospital, Nazareth, Israel
Other
Ultrasound Use Compared With Standard Care for Diagnosis of Blood Loss After Cesarean Delivery: A Randomized Controlled Trial
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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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