Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01766388 |
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Recruitment Status :
Completed
First Posted : January 11, 2013
Last Update Posted : July 9, 2014
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Sponsor:
Gynuity Health Projects
Information provided by (Responsible Party):
Gynuity Health Projects
| Tracking Information | ||||||||||
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| First Submitted Date | December 6, 2012 | |||||||||
| First Posted Date | January 11, 2013 | |||||||||
| Last Update Posted Date | July 9, 2014 | |||||||||
| Study Start Date | December 2012 | |||||||||
| Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||||||||
| Current 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 ] | |||||||||
| Original Primary Outcome Measures |
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| 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 | |||||||||
| 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 | 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 Type | Observational | |||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| 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 | |||||||||
| Condition | Abortion in Second Trimester | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Pregnant women
Pregnant women of 13-22 weeks gestation
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
120 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Actual Study Completion Date | December 2013 | |||||||||
| Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Armenia | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01766388 | |||||||||
| Other Study ID Numbers | 1005 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | Gynuity Health Projects | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Gynuity Health Projects | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Gynuity Health Projects | |||||||||
| Verification Date | July 2014 | |||||||||