NCT01856777

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Medical Abortion

Interventions

Type	Name	Description
DEVICE	Semi-quantitative panel test
DEVICE	High sensitivity urine pregnancy test

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-05-17
• Last updated: 2014-05-14

Locations

2 sites across 1 country: Vietnam