Actively Recruiting

Age: 20Years - 50Years
FEMALE
ID07101770

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

Led by Peking University People's Hospital · Updated on 2025-12-01

300

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

P

Peking University People's Hospital

Lead Sponsor

T

Tianjin Medical University General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pregnant women with aplastic anemia (AA), a rare blood disorder causing bone marrow failure and low blood counts, face serious risks including heavy bleeding, infections, and complications for their babies like preterm birth and restricted growth. This research aims to develop and validate a tool to predict adverse pregnancy outcomes in women with AA, helping guide early clinical decisions and improve health for mothers and infants. The study combines retrospective and prospective data collection across multiple centers to address the current lack of comprehensive data in this area. The study involves observing pregnant women diagnosed with AA either before or during their pregnancy. Researchers will gather baseline information and diagnostic data, then follow participants regularly through questionnaires, phone calls, video consultations, online platforms, and in-person visits. They will record treatments, other health conditions, and pregnancy outcomes, aiming to build a prediction model for adverse outcomes. Participants will be monitored from their first hospital visit during pregnancy until 42 days after delivery. Data collected includes clinical assessments and neonatal Apgar scores shortly after birth. The study will provide detailed information on the health and risks for mothers and babies affected by AA during pregnancy, helping improve care strategies. The total participation duration varies depending on the timing of enrollment and delivery.

CONDITIONS

Brief Title

A Prediction Model in Pregnant Women With Aplastic Anemia

Who Can Participate

Age: 20Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women who had aplastic anemia before pregnancy
  • Pregnant women with newly diagnosed aplastic anemia during pregnancy
Not Eligible

You will not qualify if you...

  • Age less than 20 years
  • Without coagulation series results
  • Termination of pregnancy before 20 weeks of gestation
  • Multiple pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Diagnostic Evaluation

Duration - From first hospital visit during pregnancy to delivery

Baseline patient information and diagnostic data are collected to understand participants' health status related to aplastic anemia during pregnancy.

1 to 2 visits depending on clinical needs

Long-term Monitoring

Duration - From first hospital visit during pregnancy to 42 days after delivery

Participants are followed prospectively through questionnaires, telephone interviews, video consultations, online platforms, and in-person visits to monitor health outcomes and treatment regimens.

Regular follow-ups via multiple methods including in-person and remote contacts

Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, China, 100044

Actively Recruiting

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Research Team

X

Xiaohui Zhang, MD

Q

Qiuyu Guo, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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