NCT02524990

Brief Summary

The purpose of this operations research study is to evaluate women's interest in and compliance with using a semiquantitative multi-level dipstick pregnancy test at home for medical abortion follow-up.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

August 11, 2015

Last Update Submit

March 3, 2016

Conditions

AbortionPregnancy Tests

Keywords

Medical abortionpregnancy tests

Outcome Measures

Primary Outcomes (1)

  • Patients' compliance in performing the semiquantitative pregnancy test and reporting results

    This will be assessed with a survey administered at the scheduled follow-up phone call. The survey will determine if the patient performed the SQPT as requested, and whether they can interpret and report the results correctly.

    Within 2 weeks after medical abortion

Study Arms (1)

Home-based follow-up with SQPT

EXPERIMENTAL

For the intervention, a semiquantitative pregnancy test (SQPT) will be performed at the health center before the participants take mifepristone, and again two weeks later by the participants, at home. Study staff will call the participants at two weeks to follow-up with the participants.

Behavioral: Home-based follow-up with SQPT

Interventions

Home-based follow-up with SQPTBEHAVIORAL

Participants will be followed-up at home. They will receive an SQPT to perform at home two weeks after enrollment, and a scheduled follow-up phone call by study providers to determine the outcome of the procedure.

Also known as: Simplified Medical Abortion Follow-Up Study
Home-based follow-up with SQPT

Eligibility Criteria

Age11 Years - 56 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • She has been determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria;
  • She is willing to use the semiquantitative pregnancy test at home;
  • She is wiling and able to comply with the study procedures;
  • She speaks and reads English;
  • She has signed the study informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carafem Health Center

Chevy Chase, Maryland, 20815, United States

Location

Study Officials

  • Elizabeth Raymond, MD,MPH

    Gynuity Health Projects

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 17, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

US(1)