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Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy

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ClinicalTrials.gov Identifier: NCT01856777
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE May 3, 2013
First Posted Date  ICMJE May 17, 2013
Last Update Posted Date May 14, 2014
Study Start Date  ICMJE June 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
Accuracy of these two types of home pregnancy tests [ Time Frame: 2 weeks ]
Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration. [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT01856777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
  • Comparison of the two types of pregnancy tests at identifying continuing pregnancy [ Time Frame: 2 weeks ]
  • The use and acceptability of the two tests [ Time Frame: 2 weeks ]
    The use and acceptability of the two tests for women as a diagnostic tool to assess pregnancy status at home following early medical abortion
  • Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
  • Compare the two types of pregnancy tests at identifying continuing pregnancy at each of these time points. [ Time Frame: 2 weeks ]
  • Compare the use and acceptability of the two tests for women as a diagnostic tool to assess pregnancy status at home following early medical abortion. [ Time Frame: 2 weeks ]
  • Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy
Official Title  ICMJE Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion
Brief Summary

This randomized study will examine the effectiveness of two types of pregnancy tests (a semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home at various time points after early medical abortion. The first test a semi-quantitative panel test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based, one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA).

  1. The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14.
  2. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7.
  3. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Medical Abortion
Intervention  ICMJE
  • Device: Semi-quantitative panel test
    Other Name: dBest (AmeriTek, Seattle WA, USA)
  • Device: High sensitivity urine pregnancy test
    Other Name: Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA
Study Arms  ICMJE
  • High sensitivity urine pregnancy test
    Standard medical care and high sensitivity urine pregnancy test
    Intervention: Device: High sensitivity urine pregnancy test
  • Semi-quantitative panel test
    Standard medical care and semi-quantitative panel test
    Intervention: Device: Semi-quantitative panel test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2013)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gestational age ≤63days from LMP
  • Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines(national guidelines stipulate that women can receive medical abortion thru 63 days LMP at Hung Vuong (tertiary level) hospital; women with gestations up to 49 days LMP can receive medical abortion at Hocmon (district) hospital)
  • Willing to follow instructions of the provider regarding use of the pregnancy tests
  • Able to read and write to use pregnancy test at home
  • Willing to be randomized to perform one of two types of urine pregnancy tests at three time points at home
  • Willing to provide an address and/or telephone number for purposes of follow-up
  • Agrees to return for follow-up visit at clinic to confirm abortion status
  • Wishes to participate in the study
  • Able to consent to study participation

Exclusion Criteria:

  • Women not meeting the above inclusion criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01856777
Other Study ID Numbers  ICMJE 6003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Nguyen Thi Nhu Ngoc, MD, MsC CRCRH
Principal Investigator: Paul Blumenthal, MD Stanford University
Principal Investigator: Wendy Sheldon, MPH, MSW, PhD Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP