Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn

February 22, 2026 updated by: Jun Zhang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
This study adopted a single-center, prospective, observational study design. A consecutive cohort of pregnant and postpartum women who met the inclusion criteria was recruited from Shanghai First People's Hospital between January 2026 and December 2028. Quantitative hemorrhage detection was performed using residual clinical blood samples, and the diagnostic value of this detection for hemolytic disease of the newborn (HDN) was analyzed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Pregnant and postpartum women
  2. Newborn

Description

Inclusion Criteria:

  • Gestational Age: Singleton pregnant women with gestational age ≥ 20 weeks.
  • Clinical High-Risk Factors (meeting at least one of the following criteria):
  • Traumatic Factors: Abdominal trauma (e.g., traffic accident, fall), intrauterine fetal version, amniocentesis, chorionic villus sampling (CVS).
  • Obstetric Complications: Placental abruption, placenta previa, preeclampsia, unexplained antenatal hemorrhage, post-interventional therapy for twin-twin transfusion syndrome (TTTS).
  • Fetal Abnormalities: Fetal growth restriction (FGR), unexplained abnormal fetal heart rate monitoring, fetal hydrops, fetal anemia (elevated middle cerebral artery peak systolic velocity (MCA-PSV) detected by Doppler ultrasound).
  • High-Risk Population with Maternal-Fetal Blood Group Incompatibility: Maternal-fetal ABO or Rh-negative blood group incompatibility; positive result of the first-trimester antenatal antibody screening in pregnant women.

Exclusion Criteria:

  • Pregnant women complicated with severe hematological diseases (e.g., coagulation disorders, immune thrombocytopenic purpura) or autoimmune diseases.
  • Newborns who withdrew treatment for non-study-related reasons or were lost to follow-up after birth, resulting in missing outcome data.
  • Termination of pregnancy due to various causes.
  • Failure to complete the analysis due to unqualified core clinical data (e.g., quantitative hemorrhage test results, bilirubin levels) or unsatisfactory specimens (hemolysis, insufficient volume).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Fetomaternal hemorrhage (FMH) values ≥ 0.5%
Fetomaternal hemorrhage (FMH) value < 0.5%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemolytic Disease of the Newborn（HDN）
Time Frame: within 72 hours after birth
All the following criteria must have been met for a diagnosis of HDN: (1) Blood group incompatibility between the mother and newborn; (2) hyperbilirubinemia with a positive direct antiglobulin test (DAT) result or hyperbilirubinemia with a negative DAT result and a positive elution testing result with high suspicion of a hemolytic condition such as anemia and/or reticulocytosis.
within 72 hours after birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anemia: hemoglobin
Time Frame: within 72 hours after birth
Hemoglobin Concentration in Peripheral Blood of Neonates
within 72 hours after birth
Incidence of severe hyperbilirubinemia
Time Frame: 30 days
The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2025-275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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