Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

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

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.

Study Overview

• Status: Completed
• Conditions: Abortion, First Trimester
• Intervention / Treatment: Drug: Home administration of 200 mg mifepristone; Drug: Home or clinic administration of 400 mcg buccal misoprostol

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.

• Study Type: Interventional
• Enrollment (Actual): 622
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Ajara
    • Batumi, Ajara, Georgia
      • Batumi Maternity House
  • Imereti
    • Zestafoni, Imereti, Georgia
      • Zestafoni Maternity House
  • Kakheti
    • Telavi, Kakheti, Georgia
      • A. Kambarashvili Clinic
  • Kvemo Kartli
    • Bolnisi, Kvemo Kartli, Georgia
      • Bolnisi Maternity House

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home administration of mifepristone; Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.	Drug: Home administration of 200 mg mifepristone; Home administration of 200 mg mifepristone.; Other Names: Penkrofton; Drug: Home or clinic administration of 400 mcg buccal misoprostol; Home or clinic administration of 400 mcg buccal misoprostol
Active Comparator: Clinic administration of mifepristone; Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.	Drug: Home or clinic administration of 400 mcg buccal misoprostol; Home or clinic administration of 400 mcg buccal misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1.2.4.5