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

Not Applicable

Completed

• Conditions: Medical Abortion
• Interventions: Device: High sensitivity urine pregnancy test; Device: Semi-quantitative panel test

• Registration Number: NCT01856777
• Lead Sponsor: Gynuity Health Projects

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 available

Study Timeline

• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-17
• Study Start: 2013-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High sensitivity urine pregnancy test	High sensitivity urine pregnancy test	Standard medical care and high sensitivity urine pregnancy test
Semi-quantitative panel test	Semi-quantitative panel test	Standard medical care and semi-quantitative panel test

Primary Outcome Measures

Name	Time	Method
Accuracy of these two types of home pregnancy tests	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 Outcome Measures

Name	Time	Method
Comparison of the two types of pregnancy tests at identifying continuing pregnancy	2 weeks
The use and acceptability of the two tests	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	2 weeks

Trial Locations

Locations (2)

Hocmon General District Hospital; 🇻🇳 Hochiminh City, Vietnam

Hungvuong Hospital; 🇻🇳 Hochiminh City, Vietnam