Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02219100

Enrollment

613

Registered

2014-08-18

Start date

2010-11-30

Completion date

2011-11-30

Last updated

2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, First Trimester

Brief summary

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.

Interventions

DRUGHome administration of 200 mg mifepristone

Home administration of 200 mg mifepristone

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* 18 years or older * 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 * Eligible for medical abortion according to the clinician's assessment * 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of abortions that are complete without surgical intervention (unit: percent).	15 days	Percentage of women with complete abortion without the need of a surgical intervention.

Secondary

Measure	Time frame	Description
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).	15 days	Woman's satisfaction with her medical abortion procedure and side effects experienced.

Other

Measure	Time frame
Proportion of Women Who Select Home-use of Mifepristone	1 week
Proportion of Women Who Select Home-use of Misoprostol	1 week

Countries

Armenia, Azerbaijan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026