Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia - Full Text View

Purpose

The primary goal of this study is to examine the efficacy and feasibility of a mifepristone combined with misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Armenia.

Condition
Abortion in Second Trimester


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia

Resource links provided by NLM:

Drug Information available for: Misoprostol Mifepristone

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Rate of successful abortion [ Time Frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total dose of misoprostol [ Time Frame: At the time of fetal and placental expulsion, up to 30 hours after the first dose ] [ Designated as safety issue: No ]
Women's satisfaction with the method [ Time Frame: At discharge, up to 5 days after enrollment ] [ Designated as safety issue: No ]
Side effects [ Time Frame: Every 3 hours, starting from the first dose of misoprostol, up to fetal and placental expulsion or 30 hours after the first dose, whichever occurs first ] [ Designated as safety issue: No ]
Women's acceptability of the side effects, buccal administration of misoprostol, and duration of procedure [ Time Frame: At discharge, up to 5 days after enrollment ] [ Designated as safety issue: No ]
Providers' acceptability of the method [ Time Frame: After all study procedures complete, at close out, up to 1.5 years after study enrollment commences ] [ Designated as safety issue: No ]
Complications including heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: Every 3 hours, starting from the first dose of misoprostol, up to fetal and placental expulsion, or 30 hours after the first dose, whichever occurs first ] [ Designated as safety issue: No ]
Induction to fetal expulsion interval [ Time Frame: Time from administration of first misoprostol dose to expulsion of the fetus, up to 30 hours after the first dose ] [ Designated as safety issue: No ]
Induction to fetal and placental expulsion interval [ Time Frame: Time from administration of first misoprostol dose to expulsion of the fetus and placenta, up to 30 hours after the first dose ] [ Designated as safety issue: No ]


Enrollment:	120
Study Start Date:	December 2012
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Pregnant women Pregnant women of 13-22 weeks gestation

Detailed Description:

Women who were deemed eligible for the study by the provider gave informed consent. They took 200 mg of mifepristone orally at the study clinic. In 24-44 hours, they returned to the clinic for induction with misoprostol. They were admitted as inpatients at the clinic and took 400 mcg of buccal misoprostol every 3 hours until the fetus and placenta were expelled. If there was no full expulsion after 10 doses of misoprostol, the provider used their discretion to determine the appropriate clinical course of action. After responding to questions about their experience with the procedure, women were discharged from the study.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All women presenting to a study clinic in Yerevan, Armenia for voluntary termination of intrauterine pregnancy with gestational ages of 13-22 weeks

Criteria

Inclusion Criteria:

Pregnancy of 13-22 weeks' gestation
Good general health
Meeting legal criteria to obtain abortion
Presenting with closed cervical os and no vaginal bleeding
Live fetus at time of presentation for service
Willingness to undergo a surgical completion if necessary
No contraindications to study procedures, according to provider
Woman willing and able to consent to procedure, either by reading consent document or by having consent document read to her
Willingness to follow study procedures

Exclusion Criteria:

Known previous transmural uterine incision
Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
Parity greater than 5
Any contraindications to vaginal delivery, including placenta previa
Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766388

Locations


Armenia
State Medical University
Yerevan, Armenia, 0025
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Yerevan, Armenia, 0078

Sponsors and Collaborators

Gynuity Health Projects

Investigators


Principal Investigator:	Ruzanna Abrahamyan, MD	Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Principal Investigator:	Gayane Abrahamyan, MD, PhD	State Medical University
Principal Investigator:	Beverly Winikoff, MD, MPH	Gynuity Health Projects

More Information


Responsible Party:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT01766388 History of Changes
Other Study ID Numbers:	1005
Study First Received:	December 6, 2012
Last Updated:	July 7, 2014
Health Authority:	Armenia: Ministry of Health

Additional relevant 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

ClinicalTrials.gov processed this record on September 28, 2016