NCT01279486

Brief Summary

Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre. Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void. Trained technicians will conduct a second test from the urine sample.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2010

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

December 24, 2010

Results QC Date

May 15, 2017

Last Update Submit

January 31, 2018

Conditions

Pregnancy

Keywords

Pregnancy,

Outcome Measures

Primary Outcomes (1)

  • Consumer Agreement

    The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample.

    During testing approximately 15 minutes

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Volunteers requesting a pregnancy test

You may qualify if:

  • year old
  • Female
  • Requesting a pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bedford General Hospital

Bedford, Bedfordshire, MK42 9DJ, United Kingdom

Location

Brook clinic

Milton Keynes, MK9 2FX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

Results Point of Contact

Title
Dr Sarah Johnson, Head of Clinical and Regulatory Affairs
Organization
SPD Swiss Precision Diagnostics GmbH/SPD Development Company Ltd
sarah.johnson@spdspark.com
01234835486

Study Officials

  • Kanagaratnam Shanmugaratnam

    National Health Service, United Kingdom

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2010

First Posted

January 19, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 2, 2018

Results First Posted

November 2, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Overview will be available after study is completed

Locations

GB(2)