Predicting pregnancy risks for women with aplastic anemia
Development and Validation of a Prediction Model for Adverse Pregnancy Outcomes in Women With Aplastic Anemia
This project will try to create a model to predict which pregnant women with aplastic anemia are most likely to have maternal or newborn complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07101770 on ClinicalTrials.gov |
What this trial studies
This multicenter study combines retrospective chart review with a prospective cohort to collect clinical, laboratory, treatment, and outcome data from pregnant women with aplastic anemia. Participants will be followed through questionnaires, phone or video visits, online platforms, and in-person visits to capture maternal and perinatal outcomes. Collected variables will include baseline demographics, coagulation and hematologic results, comorbidities, and treatments to develop a risk prediction model. The goal is to use pooled data from several Chinese hospitals to produce a validated tool for dynamic risk stratification in this rare high-risk group.
Who should consider this trial
Good fit: Pregnant women aged 20 or older who have aplastic anemia either before pregnancy or newly diagnosed during pregnancy, carrying a single fetus and with available coagulation testing, are the intended participants.
Not a fit: Women younger than 20, those with multiple pregnancies, pregnancies terminated before 20 weeks, or lacking key coagulation data are excluded and may not receive benefit from the model.
Why it matters
Potential benefit: If successful, the model could help clinicians identify high-risk pregnancies early so care can be intensified or tailored to reduce complications for mother and baby.
How similar studies have performed: Most prior reports are small, single-center retrospective series and there are currently no widely validated predictive tools for aplastic anemia in pregnancy, so this multicenter prospective approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Xiaohui Zhang, MD — Peking University People's Hospital
- Study coordinator: Xiaohui Zhang, MD
- Email: zhangxh@bjmu.edu.cn
- Phone: +8613522338836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.