Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
NCT ID: NCT04207554
Last Updated: 2021-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
132 participants
OBSERVATIONAL
2019-12-05
2020-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pregnancy Positive
Pregnant subjects within 11 weeks since the first day of last period.
Test Device-Strip Format
Sponsor's investigational device
Test Device-Cassette Format
Sponsor's investigational device
Predicate Device
Commercially available device
Pregnancy Negative
Non-pregnant subjects.
Test Device-Strip Format
Sponsor's investigational device
Test Device-Cassette Format
Sponsor's investigational device
Predicate Device
Commercially available device
Interventions
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Test Device-Strip Format
Sponsor's investigational device
Test Device-Cassette Format
Sponsor's investigational device
Predicate Device
Commercially available device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.
* Signed and dated informed consent.
Exclusion Criteria
* Adults who are unable to independently give consent for study.
* Known pregnancy (i.e. - patient appears obviously pregnant).
* Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before study start.
* History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an irregular-shaped uterus.
* Taken any of the medications of contraceptives containing estrogen in last two weeks.
* Hemodynamically unstable.
* Moderately to severely ill-appearing or in moderate to severe pain.
* Technically not possible to obtain blood or urine from the study subject.
18 Years
FEMALE
Yes
Sponsors
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Nova Clinical Solutions, Inc.
UNKNOWN
Guangzhou Wondfo Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Rui Liu, Master
Role: STUDY_CHAIR
Guangzhou Wondfo Biotech Co., Ltd
Locations
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National Insitute of Clinical Research
Garden Grove, California, United States
National Research Institute-Huntington Park
Huntington Park, California, United States
Downtown L.A. Research Center, Inc
Los Angeles, California, United States
National Research Institute-Westlake
Los Angeles, California, United States
National Research Institute-Panorama City
Panorama City, California, United States
National Research Institute-Santa Ana
Santa Ana, California, United States
Countries
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References
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WIDE L, GEMZELL CA. An immunological pregnancy test. Acta Endocrinol (Copenh). 1960 Oct;35:261-7. doi: 10.1530/acta.0.xxxv0261. No abstract available.
Batzer FR. Hormonal evaluation of early pregnancy. Fertil Steril. 1980 Jul;34(1):1-13. doi: 10.1016/s0015-0282(16)44829-6. No abstract available.
Braunstein GD, Rasor J, Danzer H, Adler D, Wade ME. Serum human chorionic gonadotropin levels throughout normal pregnancy. Am J Obstet Gynecol. 1976 Nov 15;126(6):678-81. doi: 10.1016/0002-9378(76)90518-4.
Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic production of human chorionic gonadotrophin by neoplasms. Ann Intern Med. 1973 Jan;78(1):39-45. doi: 10.7326/0003-4819-78-1-39. No abstract available.
Catt KJ, Dufau ML, Vaitukaitis JL. Appearance of hCG in pregnancy plasma following the initiation of implantation of the blastocyst. J Clin Endocrinol Metab. 1975 Mar;40(3):537-40. doi: 10.1210/jcem-40-3-537.
Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human chorionic gonadotropin from the time of implantation until the second week of pregnancy. Fertil Steril. 1982 Jun;37(6):773-8. doi: 10.1016/s0015-0282(16)46337-5.
Other Identifiers
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WF2019-01
Identifier Type: -
Identifier Source: org_study_id
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