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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01856777
First received: May 3, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Medical Abortion
Device: Semi-quantitative panel test
Device: High sensitivity urine pregnancy test

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Accuracy of these two types of home pregnancy tests [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration.


Secondary Outcome Measures:
  • Comparison of the two types of pregnancy tests at identifying continuing pregnancy [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The use and acceptability of the two tests [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
High sensitivity urine pregnancy test
Standard medical care and high sensitivity urine pregnancy test
Device: High sensitivity urine pregnancy test
Other Name: Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA
Semi-quantitative panel test
Standard medical care and semi-quantitative panel test
Device: Semi-quantitative panel test
Other Name: dBest (AmeriTek, Seattle WA, USA)

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01856777

Locations
Vietnam
Hungvuong Hospital
Hochiminh City, Vietnam
Hocmon General District Hospital
Hochiminh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01856777     History of Changes
Other Study ID Numbers: 6003
Study First Received: May 3, 2013
Last Updated: March 11, 2014
Health Authority: Vietnam: Ministry of Health
Vietnam: Ho Chi Minh City Health Service

Keywords provided by Gynuity Health Projects:
Medical Abortion
Pregnancy Test
continuing pregnancy

ClinicalTrials.gov processed this record on April 17, 2014