Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up

Medical Abortion Clinical Trial

Official title:

Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150279
• Other study ID #: 6.1.3
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2010
• Last updated: October 1, 2015
• Start date: August 2009

Study information

• Verified date: October 2015
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMexico: Secretary of Health of MexicoTunisia: La Rabta Maternity Hospital's Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study will examine the feasibility, acceptability and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early medical abortion using mifepristone+misoprostol. The study seeks to:

1. Assess the feasibility of using this test in lieu of standard one-week clinic-based follow up for determination of complete abortion status as part of normal service delivery. In Mexico, follow up will be in two weeks, as is standard care in that .

2. To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical.

3. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of clinic-based follow up for confirmation of complete medical abortion in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women age greater than or equal to 18 years

• Gestational age less than or equal to 63 days by last menstrual period (LMP), ultrasound or clinical assessment

• Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up

• Able to consent to study participation.

Inclusion Criteria for Mexico:

• Gestational age <_ 70 days from LMP

• Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines

• Willing to follow instructions of the provider regarding use of the at-home pregnancy test

• Agrees to provide test results by phone to study coordinator on morning of schedule follow-up visit

• Willing to provide an address and/or telephone number for purposes of follow-up

• Agrees to return for standard follow-up visit

• Wishes to participate in the study

• Having easy access to a telephone and transportation

• Able to consent to study participation

Exclusion Criteria:

• Women less than 18 years of age

• Women not eligible for medical abortion services

• Women unable to provide contact information

• Women unable to sign the consent form

Exclusion Criteria for Mexico:

• Women not eligible for medical abortion services

• Women unable to provide contact information

• Women unable to sign the consent form

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Medical Abortion

Locations

Country	Name	City	State
Mexico	Hospital Materno Infantil Nicolas M. Cedillo	Mexico City
Tunisia	ONFP Ben Arous	Ben Arous
Tunisia	ONFP Nabeul	Nabeul
Tunisia	ONFP Sousse	Sousse
Tunisia	Clinique du Parc	Tunis
Tunisia	Maternite de la Rabta	Tunis
United States	Family Planning Associates Group - Washington	Chicago	Illinois
United States	Family Planning Associates- Elston	Chicago	Illinois
United States	Stanford University Hospital	Palo Alto	California
United States	Planned Parenthood Mar Monte	Sacramento	California
Vietnam	HocMon District Hospital	Ho Chi Minh City

Sponsors (6)

Lead Sponsor	Collaborator
Gynuity Health Projects	Clinique du Parc, Tunisia, Maternité de la Rabta, Tunisia, Office National de la Famille et de la Population, Tunisia, Secretaría de Salud del Distrito Federal, Stanford University

Countries where clinical trial is conducted

United States,  Vietnam,  Mexico,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of women who correctly interpreted their results (in U.S. and Vietnam only)		18 months	No
Secondary	Percent of women who felt confident in using the test and would be willing to use it in place of clinic-based follow up in the future		18 months	No
Secondary	The proportion of times the provider believes that each participant correctly read her test result		18 months	No
Secondary	Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up		18 months	No
Secondary	The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies		18 months	No