Status:
UNKNOWN
Colla Corii Asini Treating Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency)
Lead Sponsor:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Conditions:
Thalassemia
Eligibility:
FEMALE
20-50 years
Phase:
PHASE4
Brief Summary
480 pregnant patients diagnosed of silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia with mild anemia will be randomly assigned to treatment group and control group. P...
Detailed Description
Thalassemia is a type of hemolytic anemia disease caused by genetic defect of synthesis in one or more globin chains. Among all the single genetic disorders thalassemia has the highest incidence rate ...
Eligibility Criteria
Inclusion
- Pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia;
- Patients with mild anemia (70 g/L≤ Hb\<100 g/L) prior to study enrollment;
- Singleton pregnancy ;
- Gestational age between 24-32 weeks;
- Patients having not received blood transfusion in the last 12 weeks;
- Written informed consent of the patient.
Exclusion
- Known history of allergy or reaction to any component of the investigational product;
- Allergic to two or more drugs;
- Patients with severe thalassemia;
- Anaemia not caused by thalassemia (e.g., iron deficiency, aplastic, megaloblastic or haemolytic anaemia) or bone marrow diseases, leukemia.
- Twin or multiple pregnancies;
- Placental Abnormality (e.g., placenta previa, multilobate placenta, placenta succenturiate, placenta cirumvallate) or polyhydramnios, oligohydramnios, fetal growth restriction, fetal anomaly;
- Patients having received hemopoieticfactors or treated by hematopoietic stem cell transplantation in the last 2 months;
- Hypersplenism or hypertensive disorder in pregnancy;
- Patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;
- 5 times or more higher plasma creatinine level than high limit of normal state;
- 5 times or more higher AST or ALT than high limit of normal state;
- Patients with mental illness;
- Patients who suffer from drug or alcohol abuse;
- Patients who addicted to smoking and drinking;
- Participation in any clinical investigational drug study within the previous 3 months;
- Patients who are regarded as ineligible for this study by investigator.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT03374111
Start Date
March 1 2018
End Date
December 30 2019
Last Update
December 27 2018
Active Locations (12)
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1
The third people's Hospital of Dongguan
Dongguan, Guangdong, China, 523326
2
Intranet of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510405
3
the first affiliated hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405
4
Department of Gynaecology and Obstetrics,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515