A Prediction Model in Pregnant Women With Aplastic Anemia

Not yet recruiting

• Conditions: Aplastic Anemia; Pregnancy; Prediction Model

• Registration Number: NCT07101770
• Lead Sponsor: Peking University People's Hospital

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Study Start: 2025-08-05
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. pregnant women who had aplastic anemia before pregnancy
2. pregnant women with newly diagnosed aplastic anemia during pregnancy

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse pregnancy outcomes	From the first visit to hospital during pregnancy to 42 days after delivery	Incident of adverse pregnany outcomes include at least one of the conditions as follows: placental abruption (ultrasound to detect a retroplacental hematoma), amniotic fluid embolism (elevated fetal squamous cells, vernix, or meconium in maternal blood; prolonged PT, APTT, low fibrinogen, and elevated D-dimers), postpartum hemorrhage (≥500 mL blood loss within 24 hours of vaginal delivery or ≥1000 mL after cesarean delivery), postpartum infection (fever, leukocytosis, etc), maternal mortality, stillbirths (fetal death occurring at ≥20 weeks of gestation), preterm birth (delivery at \<37 weeks of gestation), low birthweight ( a newborn with birth weight \<2500 g), fetal growth restriction (a fetus with estimated fetal weight or abdominal circumference \<10th percentile for gestational age), neonatal intensive care unit admission, or neonatal mortality (death of a live-born infant within the first 28 days of life).

Secondary Outcome Measures

Name	Time	Method
Neonatal Apgar Score	within 10 minutes after birth	Apgar 1-minute, 5-minute, 10-minute scores