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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01410266 |
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Date of registration:
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03/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan
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Scientific title:
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The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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2400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01410266 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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Phase 4
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Countries of recruitment
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Moldova, Republic of
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Uzbekistan
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Contacts
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Name:
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Hillary J. Bracken, PhD, MHS, MA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Beverly Winikoff, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Reproductive-age woman seeking a medical abortion
- Woman in good general health
- Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the
day of mifepristone administration
- Woman able and willing to sign consent forms
- Woman eligible for medical abortion according to clinician's assessment
- Woman agreeing to be followed up with, by phone or at a clinic visit
Exclusion Criteria:
- Woman with a pregnancy greater than 63 days gestation on the day of mifepristone
administration
Age minimum:
16 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Medical Abortion, Fetus
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Intervention(s)
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Other: Alternative follow-up
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Primary Outcome(s)
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Continued, ongoing pregnancy
[Time Frame: 1 month]
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Secondary Outcome(s)
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Percentage of women receiving other treatment for ongoing pregnancy
[Time Frame: 1 month]
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Percentage of women who return for follow-up
[Time Frame: 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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