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

Gynuity Health Projects

Status: Completed

Conditions: Medical Abortion

Treatments: Device: High sensitivity urine pregnancy test; Device: Semi-quantitative panel test

Study type: Interventional

Funder types: Other

Identifiers

NCT01856777

6003

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

High sensitivity urine pregnancy test

Other group

Description:

Standard medical care and high sensitivity urine pregnancy test

Treatment:

Device: High sensitivity urine pregnancy test

Semi-quantitative panel test

Other group

Description:

Standard medical care and semi-quantitative panel test

Treatment:

Device: Semi-quantitative panel test