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

This study is currently recruiting participants.
Verified January 2013 by Gynuity Health Projects
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01766388
First received: December 6, 2012
Last updated: January 9, 2013
Last verified: January 2013
  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
Women, Pregnant
13-22 Weeks Gestation

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 ]
  • 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 ]

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 ]

Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant women
Pregnant women of 13-22 weeks gestation

  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, aside from being in good general health and have a pregnancy of 13-22 weeks gestation:

  1. Meet legal criteria to obtain abortion
  2. Present with closed cervical os and no vaginal bleeding
  3. Live fetus at time of presentation for service
  4. Be willing to undergo a surgical completion if necessary
  5. Have no contraindications to study procedures, according to provider
  6. Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her
  7. Be willing to follow study procedures

Exclusion criteria:

  1. Known previous transmural uterine incision
  2. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
  3. Parity greater than 5.
  4. Any contraindications to vaginal delivery, including placenta previa
  5. Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766388

Locations
Armenia
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology Recruiting
Yerevan, Armenia, 0078
Contact: Ruzanna Abrhamyan, MD    (+374 91) 40 57 18    r_abrahamyan@mail.ru   
Principal Investigator: Ruzanna Abrahamyan, MD         
State Medical University Recruiting
Yerevan, Armenia, 0025
Contact: Gayane Avagyan, MD, PhD    (+374 91) 45 81 35    gavagyan@moh.am   
Principal Investigator: Gayane Avagyan, MD, PhD         
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: January 9, 2013
Health Authority: Armenia: Ministry of Health

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on April 17, 2014