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

NCT ID: NCT01856777

Last Updated: 2014-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Medical Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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High sensitivity urine pregnancy test

Standard medical care and high sensitivity urine pregnancy test

Group Type OTHER

High sensitivity urine pregnancy test

Intervention Type DEVICE

Semi-quantitative panel test

Standard medical care and semi-quantitative panel test

Group Type OTHER

Semi-quantitative panel test

Intervention Type DEVICE

Interventions

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Semi-quantitative panel test

Intervention Type DEVICE

High sensitivity urine pregnancy test

Intervention Type DEVICE

Other Intervention Names

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dBest (AmeriTek, Seattle WA, USA) Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Nguyen Thi Nhu Ngoc, MD, MsC

Role: PRINCIPAL_INVESTIGATOR

CRCRH

Paul Blumenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Wendy Sheldon, MPH, MSW, PhD

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Hocmon General District Hospital

Hochiminh City, , Vietnam

Site Status

Hungvuong Hospital

Hochiminh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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6003

Identifier Type: -

Identifier Source: org_study_id

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