Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
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ClinicalTrials.gov Identifier: NCT01766388 |
Recruitment Status :
Completed
First Posted : January 11, 2013
Last Update Posted : July 9, 2014
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Condition or disease |
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Abortion in Second Trimester |
Study Type : | Observational |
Actual Enrollment : | 120 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |
Group/Cohort |
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Pregnant women
Pregnant women of 13-22 weeks gestation
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- Rate of successful abortion [ Time Frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose ]
- Total dose of misoprostol [ Time Frame: At the time of fetal and placental expulsion, up to 30 hours after the first dose ]
- Women's satisfaction with the method [ Time Frame: At discharge, up to 5 days after enrollment ]
- 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 ]
- 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 ]
- Providers' acceptability of the method [ Time Frame: After all study procedures complete, at close out, up to 1.5 years after study enrollment commences ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

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): NCT01766388
Armenia | |
State Medical University | |
Yerevan, Armenia, 0025 | |
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology | |
Yerevan, Armenia, 0078 |
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 |
Responsible Party: | Gynuity Health Projects |
ClinicalTrials.gov Identifier: | NCT01766388 |
Other Study ID Numbers: |
1005 |
First Posted: | January 11, 2013 Key Record Dates |
Last Update Posted: | July 9, 2014 |
Last Verified: | July 2014 |