Observational study of pregnancy kit for rapid detection of pregnancy.
- Registration Number
- CTRI/2023/11/059697
- Lead Sponsor
- Mankind Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method