Predicting pregnancy risks for women with aplastic anemia
Official title: Development and Validation of a Prediction Model for Adverse Pregnancy Outcomes in Women With Aplastic Anemia
Run by Peking University People's Hospital · NCT07101770 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 20 Years to 50 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | November 27, 2025 |
| Main results expected | June 30, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07101770 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.