A Prediction Model in Pregnant Women With Aplastic Anemia

Last updated: November 27, 2025
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Red Blood Cell Disorders

Anemia

Pregnancy

Treatment

A combined retrospective and prospective observational follow-up

Clinical Study ID

NCT07101770
2025PHB251-001
  • Ages 20-50
  • Female

Study Summary

Aplastic anemia (AA) is a rare haematologic disorder characterized by bone marrow failure and pancytopenia. Its occurrence during pregnancy is exceedingly rare but poses significant risks, including maternal hemorrhage, infections, and perinatal complications such as preterm birth and fetal growth restriction. Consequently, pregnancy with AA is highly perilous for both mothers and infants. Early management is critical to ensure the health of both the mother and the baby. However, there are currently no predictive tools available to assess adverse outcomes in pregnant women with AA. Our center plans to conduct a multicenter, combined retrospective and prospective cohort study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. pregnant women who had aplastic anemia before pregnancy

  2. pregnant women with newly diagnosed aplastic anemia during pregnancy

Exclusion

Exclusion Criteria:

  1. age less than 20 years

  2. without coagulation series results

  3. termination of pregnancy before 20 weeks of gestation

  4. multiple pregnancy

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: A combined retrospective and prospective observational follow-up
Phase:
Study Start date:
November 27, 2025
Estimated Completion Date:
December 31, 2030

Study Description

The gestational period, a physiological condition linked to elevated physiological stress, induces significant cardiac remodeling and systemic hemodynamic adaptations in maternal organisms. AA, a rare but life-threatening hematologic disorder characterized by pancytopenia and bone marrow hypoplasia, poses profound challenges during pregnancy, with significant risks of maternal and perinatal morbidity and mortality. Physiological adaptations in pregnancy, including hemodilution and increased metabolic demands, exacerbate AA-related hematologic deficits, elevating risks of severe anemia, thrombocytopenia-related hemorrhage, and immunosuppression-associated infections. These outcomes underscore the critical need for dynamic risk stratification and tailored interventions.

Currently, most cohort studies on pregnant women with AA in China are retrospective, single-center studies with small sample sizes, resulting in insufficient data and a lack of multicenter, prospective cohort studies.

This study is a multicenter, retrospective and prospective observational study that will enroll pregnant women with aplastic anemia. It will collect baseline patient information and diagnostic data, conduct regular prospective follow-ups via questionnaires, telephone interviews, video consultations, online platforms, and in-person visits, and record treatment regimens, comorbidities, and prognostic outcomes. The study aims to provide comprehensive data on the epidemiology and clinical outcomes of pregnant women with aplastic anemia in China, and aimed to develop and validate a predictive model for adverse pregnancy outcomes in pregnant women with AA, with the goal of guiding early clinical decision-making and improving their overall health outcomes.

Connect with a study center

  • Peking University People's Hospital

    Beijing 1816670, 100044
    China

    Active - Recruiting

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