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History of Changes for Study: NCT01766388
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
Latest version (submitted July 7, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 9, 2013 None (earliest Version on record)
2 July 7, 2014 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Eligibility, Study Design, Conditions and Study Description
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Study NCT01766388
Submitted Date:  January 9, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1005
Brief Title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
Official Title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2013
Overall Status: Recruiting
Study Start: December 2012
Primary Completion: November 2013 [Anticipated]
Study Completion:
First Submitted: December 6, 2012
First Submitted that
Met QC Criteria:
January 9, 2013
First Posted: January 11, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 9, 2013
Last Update Posted: January 11, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Gynuity Health Projects
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Women, Pregnant
13-22 Weeks Gestation
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 120 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Pregnant women
Pregnant women of 13-22 weeks gestation
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of successful abortion
[ Time Frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose ]

2. 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 ]

3. 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 ]

Secondary Outcome Measures:
1. Total dose of misoprostol
[ Time Frame: At the time of fetal and placental expulsion, up to 30 hours after the first dose ]

2. Women's satisfaction with the method
[ Time Frame: At discharge, up to 5 days after enrollment ]

3. 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 ]

4. 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 ]

5. Providers' acceptability of the method
[ Time Frame: After all study procedures complete, at close out, up to 1.5 years after study enrollment commences ]

6. 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 ]

Open or close this module Eligibility
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
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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)
Open or close this module Contacts/Locations
Study Officials: Ruzanna Abrahamyan, MD
Principal Investigator
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Gayane Abrahamyan, MD, PhD
Principal Investigator
State Medical University
Beverly Winikoff, MD, MPH
Principal Investigator
Gynuity Health Projects
Locations: Armenia
State Medical University
[Recruiting]
Yerevan, Armenia, 0025
Contact:Contact: Gayane Avagyan, MD, PhD (+374 91) 45 81 35 gavagyan@moh.am
Contact:Principal Investigator: Gayane Avagyan, MD, PhD
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
[Recruiting]
Yerevan, Armenia, 0078
Contact:Contact: Ruzanna Abrhamyan, MD (+374 91) 40 57 18 r_abrahamyan@mail.ru
Contact:Principal Investigator: Ruzanna Abrahamyan, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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