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NCT Number: NCT07101770

A Prediction Model in Pregnant Women With Aplastic Anemia

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.

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Key information

Conditions

Aplastic Anemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Hematologic Diseases Hemic and Lymphatic Diseases Prediction Model Pregnancy

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, 100044, China

Location status: Recruiting

Location contact

Xiaohui Zhang, MD

CONTACT

[email protected]

+8613522338836

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women who had aplastic anemia before pregnancy
  • pregnant women with newly diagnosed aplastic anemia during pregnancy

Exclusion criteria

  • age less than 20 years
  • without coagulation series results
  • termination of pregnancy before 20 weeks of gestation
  • multiple pregnancy

Treatment and study plan

A combined retrospective and prospective observational follow-up

Other

A combined retrospective and prospective observational follow-up

Primary outcomes

  1. Number of participants with Adverse pregnancy outcomes

    Time frame: 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 outcomes

  1. Neonatal Apgar Score

    Time frame: within 10 minutes after birth

    Apgar 1-minute, 5-minute, 10-minute scores

Study contacts

Contact information is provided by the study sponsor or research team.

Qiuyu Guo, MD

CONTACT

[email protected]

+8613661094882

Xiaohui Zhang, MD

CONTACT

[email protected]

+8613522338836

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Chinese PLA General Hospital
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Zhejiang University
  • General Hospital of Ningxia Medical University
  • Lanzhou University Second Hospital
  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • Peking University Third Hospital
  • Qilu Hospital of Shandong University
  • Second Xiangya Hospital of Central South University
  • Shandong Provincial Hospital
  • Shanxi Bethune Hospital
  • Shanxi Provincial People's Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of Zhengzhou University
  • The Third Affiliated Hospital of Guangzhou Medical University
  • Tianjin Medical University General Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan TongJi Hospital
  • Yantai Yuhuangding Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 3, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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