Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398838
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

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.

Condition or disease Intervention/treatment Phase
Abortion, First Trimester Drug: Home administration of 200 mg mifepristone Drug: Home or clinic administration of 400 mcg buccal misoprostol Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 622 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : December 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Proportion of abortions that are complete without surgical intervention (unit: percent) [ Time Frame: 15 days ]
    Percentage of women with complete abortion without the need of a surgical intervention.


Secondary Outcome Measures :
  1. Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent) [ Time Frame: 15 days ]
    Woman's satisfaction with her medical abortion procedure and side effects experienced.


Other Outcome Measures:
  1. Proportion of women who select home-use of mifepristone [ Time Frame: 1 week ]
  2. Proportion of women who select home-use of misoprostol [ Time Frame: 1 week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398838


Locations
Layout table for location information
Georgia
Batumi Maternity House
Batumi, Ajara, Georgia
Zestafoni Maternity House
Zestafoni, Imereti, Georgia
A. Kambarashvili Clinic
Telavi, Kakheti, Georgia
Bolnisi Maternity House
Bolnisi, Kvemo Kartli, Georgia
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Layout table for investigator information
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects

Layout table for additonal information
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02398838     History of Changes
Other Study ID Numbers: 1.2.4.5
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents