NCT06963047

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 19, 2025

Last Update Submit

April 7, 2026

Conditions

Postpartum Period

Keywords

Postpartum anemiaPostpartum hemorrhageUltrasoundCesarean sectionIntra-abdominal bleeding

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin drop of 2g% or more within 24 - 36 hours

    The proportion of women with a decrease in Hb levels of over 2 g% identified within 24 hours of surgery in both groups.

    24 -72 hours

Secondary Outcomes (18)

  • HB levels after 48-72

    72 hours postpartum

  • Inferior Vena Cava (IVC) diameter

    up to 72 hours postpartum

  • IVC collapsibility index

    up to 72 hours postpartum

  • Uterine walls diameter

    up to 72 hours postpartum

  • Uterine endometrial diameter

    up to 72 hours postpartum

  • +13 more secondary outcomes

Study Arms (2)

Ultrasound group

ACTIVE COMPARATOR

Group 1: patients will undergo an abdominal and transvaginal ultrasound examination within 24 - 48 hours post-surgery.

Diagnostic Test: Ultrasound

Standard care group

ACTIVE COMPARATOR

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

Other: Standard care

Interventions

UltrasoundDIAGNOSTIC_TEST

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

Ultrasound group
Standard careOTHER

Routine management

Standard care group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holy family hospital

Nazareth, North, Israel

RECRUITING

MeSH Terms

Conditions

Postpartum HemorrhageHemoperitoneum

Interventions

UltrasonographyStandard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPeritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Raed Salim, MD

    Holy Family Hospital, Nazareth, Israel

    STUDY CHAIR

Central Study Contacts

Raed Sa, MD

CONTACT

+972544986960r.salim@hfhosp.org

Bassam Abboud, MD

CONTACT

+972526792999Dr.bassamabb@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of obstetrics and gynecology departement

Study Record Dates

First Submitted

April 19, 2025

First Posted

May 8, 2025

Study Start

May 8, 2025

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

IL(1)