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

Medical Abortion Clinical Trial

Official title:

Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856777
• Other study ID #: 6003
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: May 12, 2014
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of HealthVietnam: Ho Chi Minh City Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Device:
• Semi-quantitative panel test

• High sensitivity urine pregnancy test

Locations

Country	Name	City	State
Vietnam	Hocmon General District Hospital	Hochiminh City
Vietnam	Hungvuong Hospital	Hochiminh City

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison of the two types of pregnancy tests at identifying continuing pregnancy		2 weeks	No
Secondary	The use and acceptability of the two tests	The use and acceptability of the two tests for women as a diagnostic tool to assess pregnancy status at home following early medical abortion	2 weeks	No
Secondary	Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider		2 weeks	No