None listed
Conditions
Interventions
Control Intervention1: Nil: Nil
Sponsors
Mankind Pharma Limited
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Number of diagnostic pregnancies with the pregnancy test kit (“Prega News Advance ?) in comparison with the number of diagnostic pregnancies with the blood determination of the ß-human chorionic gonadotropin concentration.Timepoint: 5 min to 24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMukesh Kumar
RAHE LIFE SCIENCE
Outcome results
None listed