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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01856777
First received: May 3, 2013
Last updated: May 12, 2014
Last verified: May 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 ]

Enrollment: 600
Study Start Date: June 2013
Study Completion Date: February 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 12, 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 September 18, 2014