Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

Abortion, First Trimester Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398838
• Other study ID #: 1.2.4.5
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: April 2, 2015
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2015
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Georgia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

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.
• Home or clinic administration of 400 mcg buccal misoprostol
Home or clinic administration of 400 mcg buccal misoprostol

Locations

Country	Name	City	State
Georgia	Batumi Maternity House	Batumi	Ajara
Georgia	Bolnisi Maternity House	Bolnisi	Kvemo Kartli
Georgia	A. Kambarashvili Clinic	Telavi	Kakheti
Georgia	Zestafoni Maternity House	Zestafoni	Imereti

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Georgia, 

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