Clinical trial NCT02398838: Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia
Official title: Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, First Trimester
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 622
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 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.

Detailed description: The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.

Eligibility criteria: Inclusion Criteria:

* 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

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: Batumi
country: Georgia
facility: Batumi Maternity House
state: Ajara
city: Zestafoni
country: Georgia
facility: Zestafoni Maternity House
state: Imereti
city: Telavi
country: Georgia
facility: A. Kambarashvili Clinic
state: Kakheti
city: Bolnisi
country: Georgia
facility: Bolnisi Maternity House
state: Kvemo Kartli
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: