A Multi-centric, Cross-sectional, Observational, Validation study of Pregnancy Test Kit for Rapid Detection of Pregnancy ? - NI

Mankind Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•1. Healthy female subjects of child-bearing age group of =18 to =50 years.
•2. Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment?
•3. Written informed consent from the subject, legally acceptable representative or parent and able to follow study procedures.

•1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form.
•2. Known pregnancy.
•3. Symptomatic COVID-19 suspected subjects (as per PI discretion).
•4. Hemodynamically unstable.
•5. Moderately to severely ill-appearing or in moderate to severe pain.
•6. Taken a hormonal preparation containing hCG in the last month, e.g., Pregnyl®
•7. Recently miscarried subject with in 2 months before study participation.
•8. Subject recently consumed birth control pills, Antipsychotics such as perphenazine, prochlorperazine, chlorpromazine, trifluoperazine, thioridazine and thiothixene, anti-seizure/anticonvulsant drug carbamazepine, Anti-nausea drugs, including prochlorperazine, perphenazine, chlorpromazine and promethazine etc. which can cause false positive result. .
•9. Technically not possible to obtain blood from the study subject.

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