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

Abortion, First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219100
• Other study ID #: 1.2.3.1
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: August 18, 2014
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Abortion, First Trimester

Intervention

Drug:
• Home administration of 200 mg mifepristone
Home administration of 200 mg mifepristone

Locations

Country	Name	City	State
Armenia	Gyumri Maternity Hospital	Gyumri
Armenia	Vanadzor Hospital #1	Vanadzor
Azerbaijan	Antenatal Clinic	Gandja
Azerbaijan	Family Planning Center	Gandja
Azerbaijan	Gynecology Department of the Central Regional Hospital	Zaqatala

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Armenia,  Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Women Who Select Home-use of Mifepristone		1 week	No
Other	Proportion of Women Who Select Home-use of Misoprostol		1 week	No
Primary	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	No
Secondary	Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).	Woman's satisfaction with her medical abortion procedure and side effects experienced.	15 days	No