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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06963047
Enrollment
276
Registered
2025-05-08
Start date
2025-05-08
Completion date
2027-06-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Period

Keywords

Postpartum anemia, Postpartum hemorrhage, Ultrasound, Cesarean section, Intra-abdominal bleeding

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.

Interventions

DIAGNOSTIC_TESTUltrasound

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

OTHERStandard care

Routine management

Sponsors

Holy Family Hospital, Nazareth, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin drop of 2g% or more within 24 - 36 hours24 -72 hoursThe proportion of women with a decrease in Hb levels of over 2 g% identified within 24 hours of surgery in both groups.

Secondary

MeasureTime frameDescription
HB levels after 48-7272 hours postpartumDifference in average HB levels after 48-72 hours between the two study groups
Inferior Vena Cava (IVC) diameterup to 72 hours postpartumMeasurement of IVC diameter during inspiration and expiration
IVC collapsibility indexup to 72 hours postpartumIVC expiration-IVC inspiration/IVC expiration
Uterine walls diameterup to 72 hours postpartumMeasured midway between the fundus and the cervix of the uterus
Uterine endometrial diameterup to 72 hours postpartumMeasuring the thickness of the inner layer of the uterus
Uterine lengthup to 72 hours postpartumMeasured from the external cervical os to the fundus
Maximum vertical depth of intra-abdominal fluidup to 72 hours postpartumThe measurement will be performed using abdominal and/or vaginal transducer
Urine volume in the bladderup to 72 hours postpartumThe measurement will be performed using an abdominal or vaginal transducer
Rate of women in the study group with intra-abdominal fluidup to 72 hours postpartumThe measurement will be performed using abdominal and/or vaginal transducer
Intra-abdominal fluid volumeup to 72 hours postpartumThe assessment will be performed using abdominal and/or vaginal transducer
Presence of intra-abdominal hematomasup to 72 hours postpartumThe assessment will be performed using abdominal and/or vaginal transducer
Objective assessment of intraoperative blood lossup to 72 hours postpartumCalculated blood loss = total blood volume × (prepartum hematocrit - postpartum hematocrit) + total blood volume transfused (if applicable).
Administration of blood productsup to 72 hours postpartumNumber of blood units administrated
Postoperative feverup to 72 hours postpartumMaternal fever 38C or more
Incidence of women with surgical site infectionPostoperative day 2 to day 7.An infection in the part of the body where a surgery took place
Length of hospital stayup to 10 days postpartumNumber of days from delivery to discharge
Maternal discomfort during the ultrasound examinationup to 72 hours postpartumMeasured on a scale of 1 to 5 (1 = no discomfort, 5 = very uncomfortable).
HB levels after 4 - 6 weeks6 weeks postpartumDifference in average HB levels 4 - 6 weeks between the two study groups

Countries

Israel

Contacts

CONTACTRaed Sa, MD
r.salim@hfhosp.org+972544986960
CONTACTBassam Abboud, MD
Dr.bassamabb@gmail.com+972526792999
STUDY_CHAIRRaed Salim, MD

Holy Family Hospital, Nazareth, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026