Clinical trial NCT01856777: Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy
Official title: Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion
Keywords: Medical Abortion
Pregnancy Test
continuing pregnancy
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of these two types of home pregnancy tests
timeFrame: 2 weeks
Secondary outcomes:
measure: Comparison of the two types of pregnancy tests at identifying continuing pregnancy
timeFrame: 2 weeks
measure: The use and acceptability of the two tests
timeFrame: 2 weeks
measure: Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hochiminh City
country: Vietnam
facility: Hocmon General District Hospital
city: Hochiminh City
country: Vietnam
facility: Hungvuong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: CRCRH
name: Nguyen Thi Nhu Ngoc, MD, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Paul Blumenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Wendy Sheldon, MPH, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
References: