NCT02398838

Brief Summary

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
622

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

September 12, 2014

Last Update Submit

April 2, 2015

Conditions

Abortion, First Trimester

Outcome Measures

Primary Outcomes (1)

  • Proportion of abortions that are complete without surgical intervention (unit: percent)

    Percentage of women with complete abortion without the need of a surgical intervention.

    15 days

Secondary Outcomes (1)

  • Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent)

    15 days

Other Outcomes (2)

  • Proportion of women who select home-use of mifepristone

    1 week

  • Proportion of women who select home-use of misoprostol

    1 week

Study Arms (2)

Home administration of mifepristone

EXPERIMENTAL

Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.

Drug: Home administration of 200 mg mifepristoneDrug: Home or clinic administration of 400 mcg buccal misoprostol

Clinic administration of mifepristone

ACTIVE COMPARATOR

Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.

Drug: Home or clinic administration of 400 mcg buccal misoprostol

Interventions

Home administration of 200 mg mifepristoneDRUG

Home administration of 200 mg mifepristone.

Also known as: Penkrofton
Home administration of mifepristone
Home or clinic administration of 400 mcg buccal misoprostolDRUG

Home or clinic administration of 400 mcg buccal misoprostol

Clinic administration of mifepristoneHome administration of mifepristone

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least 18 years old
  • In good general health
  • Living or working close to the study site
  • Intrauterine pregnancy less than 64 days gestation
  • Willing and able to sign consent forms
  • Ready access to a telephone and emergency transportation
  • Willing to provide an address and/or telephone number for purposes of follow-up
  • Agree to comply with the study procedures and visit schedule

You may not qualify if:

  • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
  • IUD in place (IUD must be removed first)
  • Chronic renal failure
  • Concurrent long-term corticosteroid therapy
  • History of allergy to mifepristone, misoprostol or other prostaglandin
  • Hemorrhagic disorders or concurrent anticoagulant therapy
  • Inherited porphyrias
  • Other serious physical or mental health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Batumi Maternity House

Batumi, Adjara, Georgia

Location

Zestafoni Maternity House

Zestaponi, Imereti, Georgia

Location

A. Kambarashvili Clinic

Telavi, Kakheti, Georgia

Location

Bolnisi Maternity House

Bolnisi, Kvemo Kartli, Georgia

Location

MeSH Terms

Interventions

MifepristoneHome Care Services

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

March 26, 2015

Study Start

December 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

GE(4)