Clinical trial NCT06963047: Evaluation of Blood Loss After Cesarean Delivery Via US Compared to Standard Care
Official title: Ultrasound Use Compared With Standard Care for Diagnosis of Blood Loss After Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Period
Keywords: Postpartum anemia
Postpartum hemorrhage
Ultrasound
Cesarean section
Intra-abdominal bleeding
Lead sponsor: Holy Family Hospital, Nazareth, Israel
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin drop of 2g% or more within 24 hours
timeFrame: 24 -72 hours
Secondary outcomes:
measure: HB levels after 48-72
timeFrame: 72 hours postpartum
measure: Inferior Vena Cava (IVC) diameter
timeFrame: up to 72 hours postpartum
measure: IVC collapsibility index
timeFrame: up to 72 hours postpartum
measure: Uterine walls diameter
timeFrame: up to 72 hours postpartum
measure: Uterine endometrial diameter
timeFrame: up to 72 hours postpartum
measure: Uterine length
timeFrame: up to 72 hours postpartum
measure: Maximum vertical depth of intra-abdominal fluid
timeFrame: up to 72 hours postpartum
measure: Urine volume in the bladder
timeFrame: up to 72 hours postpartum
measure: Rate of women in the study group with intra-abdominal fluid
timeFrame: up to 72 hours postpartum
measure: Intra-abdominal fluid volume
timeFrame: up to 72 hours postpartum
measure: Presence of intra-abdominal hematomas
timeFrame: up to 72 hours postpartum
measure: Objective assessment of intraoperative blood loss
timeFrame: up to 72 hours postpartum
measure: Administration of blood products
timeFrame: up to 72 hours postpartum
measure: Postoperative fever
timeFrame: up to 72 hours postpartum
measure: Incidence of women with surgical site infection
timeFrame: Postoperative day 2 to day 7.
measure: Length of hospital stay
timeFrame: up to 10 days postpartum
measure: Maternal discomfort during the ultrasound examination
timeFrame: up to 72 hours postpartum
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Holy family hospital
state: North
Study officials:
affiliation: Holy Family Hospital, Nazareth, Israel
name: Raed Salim, MD
role: STUDY_CHAIR
References: