NCT01856777

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. 1.The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14.
  2. 2.The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7.
  3. 3.The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

May 3, 2013

Last Update Submit

May 12, 2014

Conditions

Medical Abortion

Keywords

Medical AbortionPregnancy Testcontinuing pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Comparison of the two types of pregnancy tests at identifying continuing pregnancy

    2 weeks

  • The use and acceptability of the two tests

    2 weeks

  • Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider

    2 weeks

Study Arms (2)

High sensitivity urine pregnancy test

OTHER

Standard medical care and high sensitivity urine pregnancy test

Device: High sensitivity urine pregnancy test

Semi-quantitative panel test

OTHER

Standard medical care and semi-quantitative panel test

Device: Semi-quantitative panel test

Interventions

Semi-quantitative panel testDEVICE
Also known as: dBest (AmeriTek, Seattle WA, USA)
Semi-quantitative panel test
High sensitivity urine pregnancy testDEVICE
Also known as: Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA
High sensitivity urine pregnancy test

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hocmon General District Hospital

Hochiminh City, Vietnam

Location

Hungvuong Hospital

Hochiminh City, Vietnam

Location

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Nguyen Thi Nhu Ngoc, MD, MsC

    CRCRH

    PRINCIPAL INVESTIGATOR

  • Paul Blumenthal, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Wendy Sheldon, MPH, MSW, PhD

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 17, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

VN(2)