| Trial registration number
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TCTR20210717002 |
Full text link
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20210717002
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First author
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Chenchit Chayachinda
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Contact
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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chenchit.cha@mahidol.ac.th
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Registration date
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-07-17
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Recruitment status
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Singleton pregnancy
2. Alive, intrauterine pregnancy
3. Gestational age >,12 weeks
4. Literacy in Thai
5. Thai language literacy
6. Able to use applications e.g. Google form, Line
7. Able to comply follow-up schedules
8. Willing to participate in the study
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Exclusion criteria
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. History of uterine bleeding >,2 times in the current pregnancy
2. Having uterine bleeding on the enrollment day
3. History of or having pre-eclampsia, abnormal placental position, preterm labor, fetal growth restriction
4. History of cigarettes smoking, alcohol drinking, recreational drugs
5. Recent immunization in prior 14 days
6. Previous COVID-19 immunization
7. Detection of COVID-19 in prior 90 days
8. Blood transfusion in prior 90 days
9. History of severe drug hypersensitivity
10. Type 1, 2 diabetes mellitus
11. Hypertension
12. Having uncontrollable diseases
13. Immunocompromised conditions, including steroid use
14. Investigators', judgement
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Number of arms
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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5
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Funding
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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National Research Council of Thailand (NRCT)
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Inclusion age min
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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45
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Countries
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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165
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primary outcome
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Adverse events Delivery Descriptive statistics
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Notes
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 219, "treatment_name": "Bnt162", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1444, "treatment_name": "Chadox1 ncov-19+coronavac", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1443, "treatment_name": "Bnt162b2+chadox1 ncov-19", "treatment_type": "Rna based vaccine+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1966, "treatment_name": "Bnt162b2+coronavac", "treatment_type": "Rna based vaccine+inactivated virus", "pharmacological_treatment": "Vaccine"}]
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