Aplastic Anemia, Prediction Model, Pregnancy
Conditions
Keywords
aplastic anemia, pregnancy, prediction model
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.
Interventions
A combined retrospective and prospective observational follow-up
Sponsors
Tianjin Medical University General Hospital
Lanzhou University Second Hospital
The Affiliated Hospital of Inner Mongolia Medical University
General Hospital of Ningxia Medical University
Peking Union Medical College Hospital
Peking University Third Hospital
The First Affiliated Hospital of Anhui Medical University
Wuhan TongJi Hospital
Peking University First Hospital
Chinese PLA General Hospital
Second Xiangya Hospital of Central South University
The First Affiliated Hospital of Soochow University
Qilu Hospital of Shandong University
Shanxi Provincial People's Hospital
The First Affiliated Hospital of Zhengzhou University
Shandong Provincial Hospital
Shanxi Bethune Hospital
Yantai Yuhuangding Hospital
First Affiliated Hospital of Harbin Medical University
The Third Affiliated Hospital of Guangzhou Medical University
First Affiliated Hospital of Zhejiang University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Apgar Score | within 10 minutes after birth | Apgar 1-minute, 5-minute, 10-minute scores |
Countries
China
Contacts
Primary ContactXiaohui Zhang, MD
Backup ContactQiuyu Guo, MD
Outcome results
None listed