## Protocol Section
### Identification Module
**NCT ID:** NCT01150279

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

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

#### Organization Study ID Info
**ID:** 6.1.3
#### Organization
**Class:** OTHER
**Full Name:** Gynuity Health Projects
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-10-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-10-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-05

**Type:** ACTUAL

#### Start Date
**Date:** 2009-08

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2010-06-24
**Type:** ESTIMATED
**Study First Submit Date:** 2010-05-13
**Study First Submit QC Date:** 2010-06-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Stanford University

**Class:** UNKNOWN

**Name:** Secretaría de Salud del Distrito Federal

**Class:** UNKNOWN

**Name:** Office National de la Famille et de la Population, Tunisia

**Class:** UNKNOWN

**Name:** Maternité de la Rabta, Tunisia

**Class:** UNKNOWN

**Name:** Clinique du Parc, Tunisia

#### Lead Sponsor

**Class:** OTHER

**Name:** Gynuity Health Projects

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Medical Abortion

**Keywords:**

- medical abortion

- Medical Abortion Follow Up Care

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1200

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Percent of women who correctly interpreted their results (in U.S. and Vietnam only)

**Time Frame:** 18 months

#### Secondary Outcomes

**Measure:** 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

**Time Frame:** 18 months

**Measure:** The proportion of times the provider believes that each participant correctly read her test result

**Time Frame:** 18 months

**Measure:** Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up

**Time Frame:** 18 months

**Measure:** The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies

**Time Frame:** 18 months

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Women presenting to clinic seeking medical abortion

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Palo Alto

**Country:** United States

**Facility:** Stanford University Hospital

**State:** California

**Location 2:**

**City:** Sacramento

**Country:** United States

**Facility:** Planned Parenthood Mar Monte

**State:** California

**Location 3:**

**City:** Chicago

**Country:** United States

**Facility:** Family Planning Associates Group - Washington

**State:** Illinois

**Location 4:**

**City:** Chicago

**Country:** United States

**Facility:** Family Planning Associates- Elston

**State:** Illinois

**Location 5:**

**City:** Mexico City

**Country:** Mexico

**Facility:** Hospital Materno Infantil Nicolas M. Cedillo

**Location 6:**

**City:** Ben Arous

**Country:** Tunisia

**Facility:** ONFP Ben Arous

**Location 7:**

**City:** Nabeul

**Country:** Tunisia

**Facility:** ONFP Nabeul

**Location 8:**

**City:** Sousse

**Country:** Tunisia

**Facility:** ONFP Sousse

**Location 9:**

**City:** Tunis

**Country:** Tunisia

**Facility:** Clinique du Parc

**Location 10:**

**City:** Tunis

**Country:** Tunisia

**Facility:** Maternite de la Rabta

**Location 11:**

**City:** Ho Chi Minh City

**Country:** Vietnam

**Facility:** HocMon District Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Paul D Blumenthal, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Gynuity Health Projects

**Name:** Beverly Winikoff, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Gynuity Health Investigator

**Name:** Jennifer Blum, MPH

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Secretaría de Salud del Distrito Federal

**Name:** Patricio Sanhueza Smith, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Office National de la Famille et de la Population

**Name:** Rym Fayala, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Maternité de la Rabta

**Name:** Ezzedine Sfar

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** Clinique du Parc

**Name:** Hella Chelli

**Role:** PRINCIPAL_INVESTIGATOR

**Official 8:**

**Affiliation:** Gynuity Health Projects

**Name:** Rasha Dabash, MPH

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Dabash R, Shochet T, Hajri S, Chelli H, Hassairi AE, Haleb D, Labassi H, Sfar E, Temimi F, Koenig L, Winikoff B. Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia. BMC Womens Health. 2016 Jul 30;16:49. doi: 10.1186/s12905-016-0327-1.

**PMID:** 27475998

**Citation:** Lynd K, Blum J, Ngoc NT, Shochet T, Blumenthal PD, Winikoff B. Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up. Int J Gynaecol Obstet. 2013 May;121(2):144-8. doi: 10.1016/j.ijgo.2012.11.022. Epub 2013 Mar 7.

**PMID:** 23477704

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
