CTRI/2023/11/059697
Not yet recruiting
未知
A Multi-centric, Cross-sectional, Observational, Validation study of Pregnancy Test Kit for Rapid Detection of Pregnancy ? - NI
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mankind Pharma Limited
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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