Abortion in Second TrimesterNCT01766388
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
An observational study of Abortion in Second Trimester, run by Gynuity Health Projects at 2 sites in Armenia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Abortion in Second Trimester
- How many people
- 120 participants
- Where
- 2 sitesArmenia
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Armenia2 sites
State Medical University
Yerevan, 0025
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Yerevan, 0078
About this study
Official title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia
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.
Read the 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.
- Conditions
- Abortion in Second Trimester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women of 13-22 weeks gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful abortion
Measured: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose
Secondary outcomes (8)
Total dose of misoprostol
Measured: At the time of fetal and placental expulsion, up to 30 hours after the first dose
Women's satisfaction with the method
Measured: At discharge, up to 5 days after enrollment
Side effects
Measured: 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
Measured: At discharge, up to 5 days after enrollment
Providers' acceptability of the method
Measured: 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
Measured: 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
Measured: 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
Measured: Time from administration of first misoprostol dose to expulsion of the fetus and placenta, up to 30 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion in Second TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruzanna Abrahamyan, MD, Principal investigator, Republican Institute of Reproductive Health, Perinatology, Obstetrics and GynecologyGayane Abrahamyan, MD, PhD, Principal investigator, State Medical UniversityBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766388
- Sponsor's protocol ID
- 1005
- Status last verified
- Jul 2014
- First submitted
- 6 Dec 2012
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia
- ClinicalTrials.gov ID
- NCT01766388
- Acronym / sponsor ID
- 1005
- Conditions
- Abortion in Second Trimester
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women of 13-22 weeks gestation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of successful abortion
Time frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
Related trials for Abortion in Second Trimester
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
Not yet recruitingObservational study
Misoprostol in Missed Abortion
Abortion; Attempted
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion in Second Trimester, run by Gynuity Health Projects at 2 sites in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful abortion (time frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.