A Prediction Model in Pregnant Women With Aplastic Anemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-50
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pregnant women who had aplastic anemia before pregnancy
pregnant women with newly diagnosed aplastic anemia during pregnancy
Disqualifiers
age less than 20 years
without coagulation series results
termination of pregnancy before 20 weeks of gestation
multiple pregnancy
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
A combined retrospective and prospective observational follow-up
Other interventionA combined retrospective and prospective observational follow-up
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: with adverse pregnancy outcomes1 intervention
Group B: without adverse pregnancy outcomes1 intervention
Trial outcomes
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).
Time frame
From the first visit to hospital during pregnancy to 42 days after deliverySecondary outcomes
1
Neonatal Apgar Score
Apgar 1-minute, 5-minute, 10-minute scores
Time frame
within 10 minutes after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University People's Hospital
Lead sponsor
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
Source ClinicalTrials.gov