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Observational study of pregnancy kit for rapid detection of pregnancy.

A multi-centric, cross-sectional, observational study of pregnancy test kit for rapid detection of pregnancy in subjects scheduled for detection of Pregnancy.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/03/041516
Enrollment
100
Registered
2022-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Control Intervention1: NIL: NIL

Sponsors

Mankind Pharma Limited Mankind Pharma Limited
Lead Sponsor

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: 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 assessed by the COVID-19 Questionnaire). 4. Hemodynamically unstable. 5. Moderately to severely ill-appearing or in moderate to severe pain. 6. Technically not possible to obtain blood from the study subject.

Design outcomes

Primary

MeasureTime frame
Number of diagnostic pregnancy with the pregnancy test kit in comparison with the number of diagnostic pregnancy with the blood determination of the Ã?²-human chorionic gonadotropin concentrationTimepoint: 5 min to 24 hrs.—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactMr Mukesh Kumar

RAHE LIFE SCIENCE

mukesh@rahelife.com9873038019

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026