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

NCT ID: NCT06963047

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2026-06-01

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.

Conditions

Postpartum Period

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ultrasound group

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

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Standard care group

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

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Routine management

Interventions

Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Standard care

Routine management

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Holy Family Hospital, Nazareth, Israel

OTHER

Sponsor Role: lead

Responsible Party

Raed Salim, MD

Head of obstetrics and gynecology departement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raed Salim, MD

Role: STUDY_CHAIR

Holy Family Hospital, Nazareth, Israel

Locations

Holy family hospital

Nazareth, North, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Raed Sa, MD

Role: CONTACT

r.salim@hfhosp.org

+972544986960

Bassam Abboud, MD

Role: CONTACT

Dr.bassamabb@gmail.com

+972526792999

Facility Contacts

Bassam A Abboud, MD

Role: primary

Dr.bassamabb@gmail.com

+972526792999

Other Identifiers

309-2025-HFH

Identifier Type: -

Identifier Source: org_study_id