Skip to main content
OpenTrials
Completed

NCT Number: NCT01856777

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Medical Abortion

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hocmon General District Hospital, Hochiminh City, Vietnam

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-quantitative panel test

Device

Other names: dBest (AmeriTek, Seattle WA, USA)

High sensitivity urine pregnancy test

Device

Other names: Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of the two types of pregnancy tests at identifying continuing pregnancy

    Time frame: 2 weeks

  2. 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

  3. Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 17, 2013
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.