NCT07101770

A Prediction Model in Pregnant Women With Aplastic Anemia

Development and Validation of a Prediction Model for Adverse Pregnancy Outcomes in Women With Aplastic Anemia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aplastic Anemia
• Pregnancy
• Prediction Model

Interventions

Type	Name	Description
OTHER	A combined retrospective and prospective observational follow-up	A combined retrospective and prospective observational follow-up

Timeline

• Start date: 2025-11-27
• Primary completion: 2030-06-30
• Completion: 2030-12-31
• First posted: 2025-08-03
• Last updated: 2025-12-01

Locations

1 site across 1 country: China