Clinical trial NCT02219100: Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
Official title: Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, First Trimester
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 613
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of abortions that are complete without surgical intervention (unit: percent).
timeFrame: 15 days
Secondary outcomes:
measure: Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).
timeFrame: 15 days
Other outcomes:
measure: Proportion of Women Who Select Home-use of Mifepristone
timeFrame: 1 week
measure: Proportion of Women Who Select Home-use of Misoprostol
timeFrame: 1 week
Locations:
city: Gyumri
country: Armenia
facility: Gyumri Maternity Hospital
city: Vanadzor
country: Armenia
facility: Vanadzor Hospital #1
city: Gandja
country: Azerbaijan
facility: Antenatal Clinic
city: Gandja
country: Azerbaijan
facility: Family Planning Center
city: Zaqatala
country: Azerbaijan
facility: Gynecology Department of the Central Regional Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Antenatal Clinic
name: Rena Bagirova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynecology Department of the Central Regional Hospital
name: Mehriban Huseynova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanadzor Hospital #1
name: Aram Avalyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gyumri Maternity Hospital
name: Alla Minasyan, MD
role: PRINCIPAL_INVESTIGATOR
References: