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Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
This study has been completed.
Sponsor:
Gynuity Health Projects
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
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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 ]
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 ]
- 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 ]
| 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 |
| Sexes 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
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 |
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 June 27, 2017