Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01811056
Other study ID # 1006
Secondary ID
Status Completed
Phase N/A
First received March 11, 2013
Last updated August 11, 2015
Start date April 2013
Est. completion date July 2014

Study information

Verified date August 2015
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.


Description:

This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.


Recruitment information / eligibility

Status Completed
Enrollment 401
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women 18 years and older

- seeking medical abortion services

- in general good health

- assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken

- eligible for medical abortion according to clinician and center standards.

Exclusion Criteria:

- will be followed up by beta HCG and not ultrasound

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Drug:
Mifepristone
Mifepristone use outside of the center

Locations

Country Name City State
United States Planned Parenthood of Northern New England Barre, Burlington, Rutland Vermont
United States Planned Parenthood of New York City New York New York
United States Planned Parenthood of the Great Northwest Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chong E, Frye LJ, Castle J, Dean G, Kuehl L, Winikoff B. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S. Contraception. 2015 Sep;92(3):215-9. doi: 10.1016/j.contraception.2015.06.026. Epub 2015 Jul 2. — View Citation

Swica Y, Chong E, Middleton T, Prine L, Gold M, Schreiber CA, Winikoff B. Acceptability of home use of mifepristone for medical abortion. Contraception. 2013 Jul;88(1):122-7. doi: 10.1016/j.contraception.2012.10.021. Epub 2012 Nov 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Productivity Missed days of school and/or work Additional costs for childcare or eldercare 1-2 weeks No
Other Reasons for selection of mifepristone administration site and experiences with home administration Reason Reasons for selection of mifepristone administration site and experiences with home administration 1-2 weeks No
Primary Proportion of participants who would choose outside of center administration of mifepristone again 1-2 weeks No
Primary Proportion of participants who would recommend outside-of-center administration to a friend 1-2 weeks No
Secondary Proportion of women who select outside-of-clinic use of mifepristone 1-2 weeks No
Secondary Success Rates/Method Failure Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study 1-2 weeks No
Secondary Adherence Did not take complete therapy Mifepristone not taken at scheduled time Mifepristone not taken within 63 days L.M.P. Misoprostol not taken within 48 hours of mifepristone administration Did not return for confirmation of outcome 1-2 weeks No
Secondary Provider-related outcomes Unscheduled visits to center Unscheduled calls to center/clinician on-call Provider satisfaction- better than center mifepristone, equivalent, or worse; impact on workload; impact on quality of care 1-2 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT05326854 - NAVIGATION ASSISTED CARE PROGRAM AND TERMINATION OF PREGNANCY N/A
Completed NCT04602052 - Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia N/A
Completed NCT00994734 - Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion N/A
Not yet recruiting NCT04303949 - Multi-Media E-Book for Second‐Trimester Termination Due to Fetal Anomaly N/A
Completed NCT04910958 - Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
Completed NCT03393455 - Obstetric & Pediatric Evolution Following Parental Refusal for Early Termination of Pregnancy Despite Fetal Risk
Completed NCT03877900 - A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital
Completed NCT02597699 - Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide Phase 3
Enrolling by invitation NCT03494842 - TENS for Suction Evacuation for Termination of 1st Trimester Pregnancies N/A
Completed NCT03802149 - Ulipristal Acetate for Cervical Preparation Early Phase 1