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

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

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.

Study Overview

• Status: Completed
• Conditions: Medical Abortion
• Intervention / Treatment: Device: High sensitivity urine pregnancy test; Device: Semi-quantitative panel test

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hochiminh City, Vietnam
    • Hocmon General District Hospital
  • Hochiminh City, Vietnam
    • Hungvuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: High sensitivity urine pregnancy test; Standard medical care and high sensitivity urine pregnancy test	Device: High sensitivity urine pregnancy test; Other Names: Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA
Other: Semi-quantitative panel test; Standard medical care and semi-quantitative panel test	Device: Semi-quantitative panel test; Other Names: dBest (AmeriTek, Seattle WA, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of these two types of home pregnancy tests	Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the two types of pregnancy tests at identifying continuing pregnancy		2 weeks
The use and acceptability of the two tests	The use and acceptability of the two tests for women as a diagnostic tool to assess pregnancy status at home following early medical abortion	2 weeks
Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider		2 weeks

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Nguyen Thi Nhu Ngoc, MD, MsC, CRCRH; Principal Investigator: Wendy Sheldon, MPH, MSW, PhD, Gynuity Health Projects; Principal Investigator: Paul Blumenthal, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 10, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Medical Abortion; Pregnancy Test; continuing pregnancy
• Other Study ID Numbers: 6003