A Prediction Model in Pregnant Women With Aplastic Anemia

NCT07101770 | Recruiting DMC

• 1 other identifier: 2025PHB251-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Aplastic Anemia; Pregnancy; Prediction Model

Keywords

aplastic anemia; pregnancy; prediction model

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse pregnancy outcomes

  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).

  From the first visit to hospital during pregnancy to 42 days after delivery

Secondary Outcomes (1)

• Neonatal Apgar Score

  within 10 minutes after birth

Study Arms (2)

with adverse pregnancy outcomes

Other: A combined retrospective and prospective observational follow-up

without adverse pregnancy outcomes

Other: A combined retrospective and prospective observational follow-up

Interventions

A combined retrospective and prospective observational follow-up OTHER

A combined retrospective and prospective observational follow-up

with adverse pregnancy outcomes; without adverse pregnancy outcomes

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population included pregnant women with aplastic anemia 20 years of age or older. This study was conducted in strict accordance with the Declaration of Helsinki and was approved by ethics committees or central institutional review boards of the Peking University People's Hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Study Officials

• Xiaohui Zhang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

+8613522338836; zhangxh@bjmu.edu.cn

Qiuyu Guo, MD

CONTACT

+8613661094882; qiuyu_guo@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 3, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (1)