Aplastic AnemiaNCT07101770
A Prediction Model in Pregnant Women With Aplastic Anemia
An observational study of Aplastic Anemia and Pregnancy, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Aplastic Anemia, Pregnancy, Prediction Model
- What is being tested?
- A combined retrospective and prospective observational follow-up
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- pregnant women who had aplastic anemia before pregnancy
- pregnant women with newly diagnosed aplastic anemia during pregnancy
Who cannot join
- age less than 20 years
- without coagulation series results
- termination of pregnancy before 20 weeks of gestation
- multiple pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Xiaohui Zhang, MD, +8613522338836, zhangxh@bjmu.edu.cn
About this study
Official title: Development and Validation of a Prediction Model for Adverse Pregnancy Outcomes in 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.
Read the detailed description
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.
- Conditions
- Aplastic Anemia, Pregnancy, Prediction Model
- Being tested
- A combined retrospective and prospective observational follow-up
- Keywords
- aplastic anemia, pregnancy, prediction model
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combined retrospective and prospective observational follow-upOther
A combined retrospective and prospective observational follow-up
| Study group | Role | What they receive |
|---|---|---|
| with adverse pregnancy outcomes | Not described Receives: Other: A combined retrospective and prospective observational follow-up | |
| without adverse pregnancy outcomes | Not described Receives: Other: A combined retrospective and prospective observational follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the first visit to hospital during pregnancy to 42 days after delivery
Secondary outcomes (1)
Neonatal Apgar Score
Apgar 1-minute, 5-minute, 10-minute scores
Measured: within 10 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start27 Nov 2025 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Lanzhou University Second Hospital, The Affiliated Hospital of Inner Mongolia Medical University, General Hospital of Ningxia Medical University, Peking Union Medical College Hospital, Peking University Third Hospital, The First Affiliated Hospital of Anhui Medical University, Wuhan TongJi Hospital, Peking University First Hospital, Chinese PLA General Hospital, Second Xiangya Hospital of Central South University, The First Affiliated Hospital of Soochow University, Qilu Hospital of Shandong University, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Shandong Provincial Hospital, Shanxi Bethune Hospital, Yantai Yuhuangding Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Zhejiang University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiaohui Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101770
- Sponsor's protocol ID
- 2025PHB251-001
- Status last verified
- Nov 2025
- First submitted
- 2 Jul 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prediction Model for Adverse Pregnancy Outcomes in Women With Aplastic Anemia
- ClinicalTrials.gov ID
- NCT07101770
- Acronym / sponsor ID
- 2025PHB251-001
- Conditions
- Aplastic Anemia, Pregnancy, Prediction Model
- Keywords
- aplastic anemia, pregnancy, prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Lanzhou University Second Hospital, The Affiliated Hospital of Inner Mongolia Medical University, General Hospital of Ningxia Medical University, Peking Union Medical College Hospital, Peking University Third Hospital, The First Affiliated Hospital of Anhui Medical University, Wuhan TongJi Hospital, Peking University First Hospital, Chinese PLA General Hospital, Second Xiangya Hospital of Central South University, The First Affiliated Hospital of Soochow University, Qilu Hospital of Shandong University, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Shandong Provincial Hospital, Shanxi Bethune Hospital, Yantai Yuhuangding Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Zhejiang University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 27 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- pregnant women who had aplastic anemia before pregnancy
- pregnant women with newly diagnosed aplastic anemia during pregnancy
Key exclusion criteria (4 listed)
- age less than 20 years
- without coagulation series results
- termination of pregnancy before 20 weeks of gestation
- multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A combined retrospective and prospective observational follow-upA combined retrospective and prospective observational follow-up | Other | with adverse pregnancy outcomes, without adverse pregnancy outcomes |
Primary outcome
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).
1 secondary outcome
Neonatal Apgar Score
Time frame: within 10 minutes after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaohui Zhang, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aplastic Anemia and Pregnancy, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Zhang, MD (+8613522338836, zhangxh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse pregnancy outcomes (time frame: From the first visit to hospital during pregnancy to 42 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.