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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01766388
First received: December 6, 2012
Last updated: July 7, 2014
Last verified: July 2014
  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:


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

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

No publications provided

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:
Mifepristone
Misoprostol
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 28, 2014