NCT01077583

Brief Summary

The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

5 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

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 28, 2011

Status Verified

January 1, 2011

Enrollment Period

1.5 years

First QC Date

February 26, 2010

Last Update Submit

September 27, 2011

Conditions

Pregnancy

Keywords

Pregnancy testWishing to become pregnant

Outcome Measures

Primary Outcomes (1)

  • The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.

    1 year

Eligibility Criteria

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

Eligibility: Ages Eligible for study: 18 - 45 years. Gender Eligible for study Female. Healthy Volunteers Yes.

You may qualify if:

  • Provide written informed consent to participate in the study and agree to comply with study procedures.
  • Has menstrual bleeds.
  • Seeking to become pregnant.
  • Intend to seek medical care during pregnancy.

You may not qualify if:

  • Has positive pregnancy test on screening.
  • Has received medical treatment for infertility or is participating in an assisted fertility program.
  • Known condition to contra-indicate pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Radiant Research Inc

Atlanta, Georgia, 30342-1524, United States

Location

Radiant Research, Inc.

Chicago, Illinois, 60654, United States

Location

Radiant Research Inc

Edina, Minnesota, 55435, United States

Location

Radiant Research Inc

Dallas, Texas, 75321, United States

Location

Radiant Research Inc

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Larsen J, Buchanan P, Johnson S, Godbert S, Zinaman M. Human chorionic gonadotropin as a measure of pregnancy duration. Int J Gynaecol Obstet. 2013 Dec;123(3):189-95. doi: 10.1016/j.ijgo.2013.05.028. Epub 2013 Sep 3.

    PMID: 24079475DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Daily early morning urine samples

Study Officials

  • Phyllis Marx, MD

    Radiant Research

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 1, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 28, 2011

Record last verified: 2011-01

Locations

US(5)